System for preparing fortified milk compositions and UV measurement head for UV-based milk analysis

Abstract

The present disclosure provides systems, devices, and methods for obtaining fat- and protein- enriched milk from unenriched milk. As provided herein, the present disclosure encompasses a device, comprising a filtration unit for increasing the concentration of protein and fat in unenriched milk to obtain a human milk origin fortifier, as well as a UV measurement head device for measuring the fat and protein content of an enriched or unenriched milk sample.

Description

SYSTEM FOR PREPARING FORTIFIED MILK COMPOSITIONS and UV MEASUREMENT HEAD FOR UV-B ASED MILK ANALYSISCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 619,643, filed Ian. 10, 2024, the entire contents of which are incorporated herein by reference.FIELD

[0001] The present invention relates to a system and a method for obtaining a protein- and fat-enriched fraction from milk, to a protein- and fat-enriched fraction of milk obtained from the system and method, to a use thereof, and to a device and method to determine protein and fat content before and after enrichment of the milk.BACKGROUND

[0002] Nutrition for premature babies needs to be optimized for their short- and long-term outcomes to be improved. Human milk is the best food for most infants, but for an infant bom preterm or born with a low birth weight (e.g., <1500 g), the protein content of milk is not high enough to meet the requirements for the infant’s growth.

[0003] Therefore, human milk needs to be enriched with additional protein fortifiers. Most often, Cow’s Milk-Origin Fortifiers (CMOF) are used. However, these fortifiers are suboptimal due to their non-human origin. CMOFs are supplied daily for the first three to four months of life. A few companies produce Human Milk-Origin Fortifier (HMOF), but these fortifiers are very expensive as they are manufactured from pooled donations from hundreds of donors and must undergo several heating cycles, which also reduces their immunoactivity.

[0004] The system and methods described herein provide an alternative by producing concentrated fat and protein HMOF locally for infants, in some instances using their own mother’s milk. The system and method provide HMOF that is closer to the fortifiers that are produced in the neonatal intensive care unit (NICU) than the fortifiers that are manufactured from pooled donations. The method provided herein comprises applying milk to an ultrafilter to remove water and small molecules from the rest of the milk. Unlike the current state of the art,the milk applied to the ultrafilter has not been treated by acid agents and has not been delipidated.

[0005] Certain processes for obtaining protein-enriched fractions from breast milk are known and have been described, inter alia in EP 0 173 999 A2 (Biotest Pharma GmbH). The pH of the milk is reduced, and the milk is filtered using a cross-flow filtration unit. Low-molecular weight components are removed from the resulting filtrate by a second cross-flow filtration. This method is complex, contains multiple steps, and requires trained personnel and expensive equipment. Due to this complex operational cycle, the total time between milk expression from a donor and the consumption of fortified milk by an infant can take months if not years.

[0006] The current methods of preparing fortified milk are also raising concerns regarding the source of human milk donations. In most countries, it is considered unethical to take milk from donors who are stimulated by payment for their donations. These methods also raise concerns regarding the health of the donors, including potential tobacco usage or the presence of unknown substances (e.g., drugs or medicine) in the donor milk. The exact sources of the donor milk are not disclosed by the companies producing the fortified milk.

[0007] The systems and methods provided herein overcome limitations of the state of the art (e.g., long preparation time, unknown source of milk donations, unknown health status of the donors, application of acid agents, and in some instances hot temperatures) and enable fortification of human breast milk, particularly an infant’s own mother’s breast milk, on-site where breast milk is pumped and / or at point of care (e.g., at home or at a hospital).

[0008] Additionally, the UV measurement head provided herein allows for the analysis of the total protein and fat content as well as modelled carbohydrate total content and predicted total energy in the milk. Currently, most hospitals do not quantitatively analyze milk prior to feeding it to neonates. Instead, the hospital personnel apply so-called “standard” fortification, which is less beneficial than the methods provided herein as it does not account for personal rates of growth for neonates or for individual variation in macronutrients in individual batches of human milk. It has been suggested that so-called target fortification can be preferable over standard fortification for feeding neonates. However, current obstacles such as lack of trained personnel and expensive and elaborate methods of measuring the macronutrient content ofhuman milk on-site have prevented targeted fortification and personalized nutrition from being applied in routine health care of neonates.

[0009] The most commonly used current state of the art for analyzing human milk is middleinfrared spectroscopy. Instruments with these analyzers are expensive (e.g., a commercial cost of 25,000 chf) and require many preparation steps (e.g. pre-heating of the samples, sonication, careful calibration of the instrument, acquiring commercial solvents to operate the device, etc.). UV-based spectroscopy is not usually employed, in part because fat can interfere with UV absorption measurements because it is relatively opaque and cannot be easily penetrated by light. The systems and methods provided herein overcome these challenges by applying a relatively simple and low-cost UV-based method to analyze both unenriched milk and enriched milk fractions that have increased protein and fat. The enriched milk may be prepared by an enrichment system such as the enrichment device provided herein.BRIEF SUMMARY

[0010] As noted above, known systems and methods for fortifying milk for neonates require long preparation times, unknown sources of milk donations, unknown health status of donors, application of acid agents, and hot temperatures. Many known methods and systems are unsuitable for on-site for fortification of human breast milk, particularly an infant’s own mother’s breast milk. And, known systems and methods either do not analyze fortified milk, or rely on middle-infrared spectroscopy require expensive systems, pre-heating of samples, sonication, careful calibration of instrument, and use of commercial solvents. Accordingly, there is a need for improved systems and methods that address the above-identified shortcomings. Disclosed herein are systems and methods that may address one or more of the above-identified shortcomings.

[0011] In some aspects, provided is a system for obtaining a protein- and fat-enriched fraction from human or animal milk. In some aspects, the system is used on-site, simplifying the process of obtaining a protein- and fat-enriched fraction from milk. In some aspects, provided is a system for protein and fat enrichment of human breast milk.

[0012] In some aspects, provided is a system to enrich unenriched breast milk and quantify an amount of protein and / or fat in unenriched or enriched breast milk, comprising: an enrichmentdevice, configured to obtain a protein and fat enriched fraction from the unenriched breast milk, wherein the enrichment device comprises: a filtration unit comprising an ultrafilter; and a reservoir, wherein the filtration unit is configured to separate a protein and fat enriched retentate from a protein and fat reduced filtrate; a first program comprising a first set of executable instructions configured to control one or more parameters of the enrichment device; a UV measurement head, configured to measure UV absorbance of a sample comprising unenriched or enriched breast milk; and a second program comprising a second set of executable instructions configured to quantify the amount of protein and / or fat in unenriched or enriched breast milk.

[0013] In some aspects, provided is a system to enrich unenriched breast milk and quantify an amount of protein and / or fat in unenriched or enriched breast milk, comprising: an enrichment device, configured to obtain a protein and fat enriched fraction from the unenriched breast milk, wherein the enrichment device comprises: a filtration unit comprising an ultrafilter; and a reservoir, wherein the filtration unit is configured to separate a protein and fat enriched retentate from a protein and fat reduced filtrate; a first program comprising a first set of executable instructions configured to control one or more parameters of the enrichment device; a cooling chamber configured to cool the filtration unit; a waste container configured to collect the filtrate; and optionally a cooling chamber configured to cool the waste container: a UV measurement head, configured to measure UV absorbance of a sample comprising unenriched or enriched breast milk; and a second program comprising a second set of executable instructions configured to quantify the amount of protein and / or fat in unenriched or enriched breast milk.

[0014] In some aspects, provided is device that is a UV measurement head for quantifying the amount of protein and / or fat in a sample, wherein the sample comprises unenriched or enriched breast milk, wherein the device comprises: a LED light source configured to emit UV light; a sample chamber configured to hold the sample; one or more lens configured to focus the emitted UV light; and a UV spectrometer configured to measure UV absorbance of the sample.

[0015] In some aspects, provided is device that is a UV measurement head for quantifying the amount of protein and / or fat in a sample, wherein the sample comprises unenriched or enriched breast milk, wherein the device comprises: a LED light source configured to emit UV light; a sample chamber configured to hold the sample; one or more lens configured to focus theemitted UV light; a UV spectrometer configured to measure UV absorbance of the sample; and a thermoregulator configured to maintain the temperature of the sample chamber.

[0016] In some aspects, provided is a device that is an enrichment device, configured to obtain a protein and fat enriched fraction from unenriched breast milk, wherein the device comprises: a filtration unit comprising an ultrafilter and a reservoir, wherein the filtration unit is configured to separate a protein and fat enriched retentate from a protein and fat reduced filtrate.

[0017] In some aspects, provided is a method for enriching breast milk and quantifying an amount of protein and / or fat in unenriched or enriched breast milk, comprising: passing a sample of unenriched milk through a filtration unit comprising a filter; collecting a sample of enriched milk from a protein and fat enriched retentate; illuminating at least one of a sample comprising unenriched milk and a sample comprising enriched milk; measuring UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk, wherein the UV absorbance is measured using a UV measurement head; and quantifying an amount of protein and / or fat in said at least one of said sample comprising unenriched milk and said sample comprising enriched milk using said UV absorbance.

[0018] In some aspects, provided is a method for quantifying an amount of protein and / or fat in unenriched or enriched breast milk, comprising: illuminating at least one of a sample comprising unenriched milk and a sample comprising enriched milk; measuring UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk, wherein the UV absorbance is measured using a UV measurement head; and quantifying an amount of protein and / or fat in said at least one of said sample comprising unenriched milk and said sample comprising enriched milk using said UV absorbance.

[0019] In some aspects, provided is a method for obtaining a protein- and fat-enriched fraction from unenriched breast milk, comprising: passing a sample of unenriched breast milk through a filtration unit comprising a filter; and collecting a sample of enriched milk from a protein and fat enriched retentate.

[0020] In some aspects, a system is provided for enriching unenriched breast milk and quantifying an amount of protein and / or fat in the enriched breast milk, comprising: anenrichment device, configured to obtain a protein and fat enriched fraction from the unenriched breast milk, wherein the enrichment device comprises: a filtration unit comprising an ultrafilter for separating a protein and fat enriched retentate from a protein and fat reduced filtrate; and one or more processors and memory storing computer-readable code comprising a first set of executable instructions which, when executed by the one or more processors, control one or more controllable parameters of the enrichment device; a UV measurement head, configured to measure UV absorbance of a sample comprising the unenriched breast milk or enriched breast milk created using the retentate from the enrichment device; and wherein the instructions, when executed, cause the system to quantify the amount of protein and / or fat in the unenriched breast milk or the enriched breast milk based at least in part on the measured UV absorbance of the unenriched or enriched breast milk.

[0021] In some aspects, the ultrafilter has a nominal molecular weight limit of less than or equal to about 30 kDa.

[0022] In some aspects, the enrichment device further comprises a waste reservoir configured to receive the protein and fat reduced filtrate from the filtration unit.

[0023] In some aspects, the enrichment device further comprises a weight sensor, wherein: the weight sensor is associated with the filtration unit and is configured to provide a real-time weight reading of the protein and fat enriched retentate; or the weight sensor is associated with the waste reservoir and is configured to provide a real-time weight reading of the protein and fat reduced filtrate.

[0024] In some aspects, the enrichment device further comprises one or more pressure valves connected with the filtration unit, wherein one or more pressure valves are configured to provide a positive air pressure to the filtration unit.

[0025] In some aspects, the enrichment device further comprises one or more pressure sensors associated with each of the one or more pressure valves respectively, wherein the pressure sensors are configured to monitor the air pressure inside the filtration unit.

[0026] In some aspects, one or more pressure valves are configured to release air and decrease an air pressure inside the filtration unit.

[0027] In some aspects, the enrichment device is configured to transmit one or more parameters to the one or more processors, wherein the one or more parameters the enrichment device is configured to transmit are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of the protein and fat reduced filtrate.

[0028] In some aspects, the one or more controllable parameters of the enrichment device are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit.

[0029] In some aspects, controlling the one or more controllable parameters of the enrichment device comprises, in response to the enrichment device transmitting a weight reading of the protein and fat enriched retentate or a weight reading of the protein and fat reduced retentate, changing an air pressure inside the filtration unit, changing a stirring speed inside the filtration unit, and / or changing a temperature around the filtration unit.

[0030] In some aspects, instructions cause the system to display a user interface comprising an indication of the one or more controllable parameters of the enrichment device.

[0031] In some aspects, the UV measurement head comprises: an LED light source configured to emit UV light; a sample chamber configured to hold the sample; one or more lenses configured to focus the emitted UV light; a UV spectrometer configured to measure UV absorbance of the sample; and a cooling chamber configured to maintain a constant temperature during a measurement such that heating of the sample is mitigated, wherein the cooling chamber is provided in thermal communication with a sample cuvette.

[0032] In some aspects, quantifying the amount of protein and / or fat in the unenriched or enriched breast milk is based on the measured UV absorbance of the sample, including at least one of a first UV absorbance of the sample at a first wavelength range associated with protein content and a second UV absorbance of the sample at a second wavelength range associated with fat content.

[0033] In some aspects, the user interface comprises an indication of the quantified amount of protein and / or fat.

[0034] In some aspects, the enrichment device and the UV measurement head are separate units.

[0035] In some aspects, the instructions further cause the system to, based on the quantification of the amount of protein and / or fat in the unenriched breast milk, automatically control the one or more controllable parameters of the enrichment device.

[0036] In some aspects, a portion of the instructions for controlling the parameters of the enrichment device are associated with a first operating system integrated into the enrichment device, and wherein a portion of the instructions for quantify the amount of protein and / or fat in unenriched or enriched breast milk is associated with a second operating system that is external to the UV measurement head.

[0037] In some aspects, the quantification of the enriched breast milk is performed without: performing chemical treatment of the enriched breast milk or unenriched breast milk, heating the enriched breast milk or unenriched breast milk, centrifuging the enriched breast milk or unenriched breast milk, or sonicating the enriched breast milk or unenriched breast milk.

[0038] In some aspects, an efficiency of protein recovery in the enriched breast milk is 90% or more of the total protein content of the unenriched breast milk.

[0039] In some aspects, an efficiency of fat recovery in the enriched breast milk is 90% or more of the total fat content of the unenriched breast milk.

[0040] In some aspects, quantifying the amount of protein and / or fat in the unenriched or enriched breast milk is based on the measured UV absorbance of the sample and comprises: applying a first digital filter to data representing the UV absorbance to determine the amount of protein, wherein the first digital filter uses a window of a first size and a polynomial of one order, and the first derivative; and applying a second digital filter to the data representing the UV absorbance to determine the amount of fat, wherein the second digital filter uses a window of thefirst size and a polynomial of another order different than the order used for the first digital filter, and no derivative.

[0041] In some aspects, quantifying the amount of protein and / or fat in the unenriched or enriched breast milk is based on the measured UV absorbance of the sample and comprises processing a signal from the UV measurement head using a Partial Least Square (PLS) method.

[0042] In some aspects, the system is trained with cross-value prediction to apply the PLS method.

[0043] In some aspects, the one or more processors determine that the enrichment process is complete in response to the enrichment device transmitting a weight reading of the protein and fat enriched retentate or a weight reading of the protein and fat reduced filtrate.

[0044] In some aspects, the filtration unit comprises a bottom interior surface comprising a plurality of grooves arranged to direct flow of liquid to a center hole formed in the bottom interior surface.

[0045] In some aspects, a temperature of the sample in the UV measurement during measurement is less than or equal to 25 °C.

[0046] In some aspects, the sample in the UV measurement head is not pre-heated before measurement.

[0047] In some aspects, a UV measurement head is provided for quantifying the amount of protein and / or fat in a sample, wherein the sample comprises unenriched or enriched breast milk, wherein the UV measurement head comprises: an LED light source configured to emit UV light; a sample chamber configured to hold the sample; one or more lenses configured to focus the emitted UV light; and a UV spectrometer configured to measure UV absorbance of the sample, a cooling chamber configured to maintain a constant temperature during a measurement such that heating of the sample is prevented, wherein the cooling chamber is provided in thermal communication with a sample cuvette.

[0048] In some aspects, the UV spectrometer is calibrated using air or water.

[0049] In some aspects, the sample chamber is a cuvette comprising a cuvette cover and a cuvette bottom, wherein the cuvette cover and cuvette bottom each comprise quartz -glass.

[0050] In some aspects, the cuvette cover and cuvette bottom are separated by less than or equal to about 0.5 mm or less than or equal to about 0.2 mm when the sample chamber is closed.

[0051] In some aspects, the UV measurement head is powered by a battery.

[0052] In some aspects, the UV measurement head is configured to transmit data indicating the UV absorbance of the sample to one or more processors configured to execute a set of executable instructions for converting the UV absorbance of the sample to a UV absorbance spectrum.

[0053] In some aspects, the UV measurement head is configured to transmit data indicating the UV absorbance of the sample to one or more processors configured to execute a set of executable instructions for quantifying the amount of protein and / or fat in the sample based on the UV absorbance of the sample.

[0054] In some aspects, the instructions cause the system to model a total carbohydrate content and predict a total energy value of the sample based on the quantified amount of protein and fat and the modeled amount of carbohydrates in the sample.

[0055] In some aspects, the UV measurement head comprises a magnetic safety locker and a lid, wherein the lid comprises the LED light source, and wherein the instructions cause the LED light source to not emit UV light when the lid is open.

[0056] In some aspects, the instructions cause the system to display a user interface.

[0057] In some aspects, an enrichment device, configured to obtain a protein and fat enriched fraction from unenriched breast milk, is provided, wherein the device comprises: a filtration unit comprising an ultrafilter, wherein the filtration unit is configured to separate a protein and fat enriched retentate from a protein and fat reduced filtrate.

[0058] In some aspects, the ultrafilter has a nominal molecular weight limit of less than or equal to about 30 kDa.

[0059] In some aspects, the enrichment device further comprises a waste reservoir configured to receive the protein and fat reduced filtrate from the filtration unit.

[0060] In some aspects, the enrichment device further comprises a weight sensor, wherein: the weight sensor is associated with the filtration unit and is configured to provide a real-time weight reading of the protein and fat enriched retentate; or the weight sensor is associated with the waste reservoir and is configured to provide a real-time weight reading of the protein and fat reduced filtrate.

[0061] In some aspects, the enrichment device further comprises one or more pressure valves connected with the filtration unit, wherein one or more pressure valves are configured to provide a positive air pressure to the filtration unit.

[0062] In some aspects, the enrichment device further comprises one or more pressure sensors associated with each of the one or more pressure valves respectively, wherein the pressure sensors are configured to monitor the air pressure inside the filtration unit.

[0063] In some aspects, one or more pressure valves are configured to release air and decrease an air pressure inside the filtration unit automatically.

[0064] In some aspects, the enrichment device is configured to transmit one or more parameters one or more processors configured to execute a set of executable instructions stored in memory for controlling one or more controllable parameters of the enrichment device.

[0065] In some aspects, the one or more transmitted parameters are selected from the group consisting of: an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of the protein and fat reduced filtrate.

[0066] In some aspects, the one or more controllable parameters of the enrichment device are selected from the group consisting of: an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit.

[0067] In some aspects, executing the set of executable instructions causes the device to change an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and / or atemperature around the filtration unit in response to the enrichment device transmitting a weight reading of the protein and fat enriched retentate or a weight reading of the protein and fat reduced filtrate.

[0068] In some aspects, the instructions cause the device to provide an operating system having a user interface.

[0069] In some aspects, the memory storing the executable instructions providing the operating system is external to the enrichment device.

[0070] In some aspects, the memory storing the executable instructions providing the operating system is integrated into the enrichment device.

[0071] In some aspects, a method for enriching breast milk and quantifying an amount of protein and / or fat in unenriched or enriched breast milk is provided, comprising: passing a sample of unenriched milk through a filtration unit comprising a filter; collecting a sample of enriched milk from a protein and fat enriched retentate; illuminating at least one of a sample comprising the unenriched milk and a sample comprising the enriched milk; measuring UV absorbance of said at least one of said sample comprising the unenriched milk and said sample comprising the enriched milk, wherein the UV absorbance is measured using a UV measurement head; and quantifying an amount of protein and / or fat in said at least one of said sample comprising the unenriched milk and said sample comprising the enriched milk based on said UV absorbance.

[0072] In some aspects, the method comprises illuminating an unenriched milk sample, measuring UV absorbance of said unenriched milk sample, and quantifying an amount of protein and / or fat in said unenriched milk sample using said UV absorbance.

[0073] In some aspects, the method comprises illuminating an enriched milk sample, measuring UV absorbance of said enriched milk sample, and quantifying an amount of protein and / or fat in said enriched milk sample using said UV absorbance.

[0074] In some aspects, the method comprises illuminating an unenriched milk sample, measuring a first UV absorbance wherein the first UV absorbance is the absorbance of saidunenriched milk sample, quantifying an amount of protein and / or fat in said unenriched milk sample using said first UV absorbance, illuminating an enriched milk sample, measuring a second UV absorbance wherein the second UV absorbance is the absorbance of said enriched milk sample, and quantifying an amount of protein and / or fat in said enriched milk sample using said second UV absorbance.

[0075] In some aspects, the method further comprises monitoring one or more filtration parameters while passing the sample of unenriched milk through the filter.

[0076] In some aspects, the one or more filtration parameters are selected from the group consisting of: an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of a protein and fat reduced filtrate.

[0077] In some aspects, one or more filtration parameters are monitored using one or more processors executing a first set of executable instructions stored in memory.

[0078] In some aspects, the executable instructions cause the filtration unit to control one or more filtration parameters selected from the group consisting of: an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit.

[0079] In some aspects, the executable instructions are associated with an operating system having a user interface.

[0080] In some aspects, the method further comprises diluting the sample of unenriched breast milk or the sample of enriched breast milk to obtain the sample comprising unenriched breast milk or the sample comprising enriched breast milk.

[0081] In some aspects, the method further comprises homogenizing the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk.

[0082] In some aspects, the method further comprises breaking large micelles and aggregates in the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk.

[0083] In some aspects, breaking large micelles comprises using a vortex mixer at about 100 to about 200 rpm.

[0084] In some aspects: the UV measurement head is configured to transmit the UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk to one or more processors configured to quantify the amount of protein and / or fat in the at least one sample comprising unenriched milk or sample comprising enriched milk.

[0085] In some aspects, executing the executable instructions causes the one or more processors to cause display of a user interface indicating the quantified amount of protein and / or fat in the at least one sample comprising unenriched milk or sample comprising enriched milk.

[0086] In some aspects: one or more filtration parameters are monitored using one or more processors executing a first set of executable instructions stored in memory, the UV measurement head is configured to transmit the UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk to the one or more processors, and executing the executable instructions causes the one or more processors to quantify the amount of protein and / or fat in the at least one sample comprising unenriched milk or said sample comprising enriched milk.

[0087] In some aspects, the method further comprises converting the UV absorbance of the sample comprising unenriched milk or the sample comprising enriched milk into a UV absorbance spectrum.

[0088] In some aspects, the method further comprises comparing the UV absorbance spectrum with a reference curve that is a UV absorbance spectrum of water or air, wherein quantifying the amount of protein and / or fat is based at least in part on the comparison of the UV absorbance spectrum with the reference curve.

[0089] In some aspects, a method for quantifying an amount of protein and / or fat in unenriched or enriched breast milk is provided, comprising: illuminating at least one of a sample comprising unenriched milk and a sample comprising enriched milk; measuring UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk, wherein the UV absorbance is measured using a UV measurement head; and quantifying an amount of protein and / or fat in said at least one of said sample comprising unenriched milk and said sample comprising enriched milk based on said UV absorbance.

[0090] In some aspects, the method further comprises diluting the sample of unenriched breast milk or the sample of enriched breast milk to obtain the sample comprising unenriched breast milk or the sample comprising enriched breast milk.

[0091] In some aspects, the method further comprises homogenizing the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk.

[0092] In some aspects, the method further comprises breaking large micelles and aggregates in the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk.

[0093] In some aspects, the UV measurement head is configured to transmit the UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk to one or more processors configured to execute a set of executable instructions stored in memory, wherein executing the executable instructions causes the one or more processors to quantify the amount of protein and / or fat in the at least one sample comprising unenriched milk or said sample comprising enriched milk.

[0094] In some aspects, executing the executable instructions causes the one or more processors to provide a user interface.

[0095] In some aspects, the method further comprises converting the UV absorbance of the sample comprising unenriched milk or the sample comprising enriched milk into a UV absorbance spectrum.

[0096] In some aspects, the method further comprises comparing the UV absorbance spectrum with a reference curve that is a UV absorbance spectrum of water or air.

[0097] In some aspects, a method for obtaining a protein- and fat-enriched fraction from unenriched breast milk is provided, comprising: passing a sample of unenriched breast milk through a filtration unit comprising a filter; and collecting a sample of enriched milk from a protein and fat enriched retentate.

[0098] In some aspects, the method further comprises monitoring one or more filtration parameters while passing the sample of unenriched milk through the filter.

[0099] In some aspects, the method further comprises monitoring one or more filtration parameters selected from the group consisting of: an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of a protein and fat reduced filtrate.

[0100] In some aspects, the one or more filtration parameters are monitored using one or more processors executing instructions stored in memory.

[0101] In some aspects, executing the instructions causes the filtration unit to control one or more filtration parameters selected from the group consisting of: an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, a temperature around a waste container of the filtration unit, a position of a door of the filtration unit, and a position of the waste container.

[0102] In some aspects, executing the executable instructions causes the one or more processors to provide a user interface.

[0103] All or part of any of the above-listed embodiments may be combined with one another and / or with all or part of any other aspect, embodiment, or disclosure described elsewhere herein.DESCRIPTION OF THE FIGURES

[0104] The present application can be understood by reference to the following description taken in conjunction with the accompanying figures.

[0105] FIG. 1 depicts an exemplary schematic for one-step filtration for the preparation of human milk origin fortifier compositions.

[0106] FIGS. 2A-2C depict an exemplary system architectures for a one-step enrichment device. In FIG. 2A, the enrichment device is configured to transmit an air pressure, a stir speed, and a weight of the protein and fat enriched retentate to a program comprising a set of executable instructions, wherein the program is associated with an operating system (Cl) external to the enrichment device. Fig. 2A shows a system architecture for a one-step filtration unit where a scale is under the filtration unit. Device components and / or data depicted in FIG. 2A include: a container, a filtration temperature (T 1 ), an ambient temperature (T2), a pressure sensor input (Pl), a pressure sensor (P2), a air valve in (VI), an air valve out (V2), compressed air (CA), a pressure regulator (PR), a signal controller (I / O), a computer (Cl), a cooler shown in dashed lines maintaining a temperature of about 5 °C, a door sensor and lock, and USB communication devices. Pressure may be regulated by the pressure regulator between 0 and 10 bar.

[0107] In FIG. 2B, the enrichment device is configured to transmit an air pressure, a stir speed, and a weight of the protein and fat enriched retentate to a program comprising a set of executable instructions, wherein the program is associated with an operating system (Cl) external to the enrichment device. FIG. 2B shows a system architecture for a one-step filtration unit where a scale is under a waste reservoir, using similar labeling conventions as FIG. 2A.

[0108] In FIG. 2C, the enrichment device is configured to transmit an air pressure, a stir speed, and a weight of the protein and fat enriched retentate to a program comprising a set of executable instructions, wherein the program is associated with an operating system on a device (C2) integrated into the enrichment device. FIG. 2B shows a system architecture for a one-step filtration unit where the system is operated by an operating system via a touch-screen, using similar labeling conventions as FIG. 2A.

[0109] FIG. 2D. depicts an exemplary device: photo of device (1), drawing of device (2) and internal composition of device (3) with key elements such as bacterial removal filter, disposable tube and second air filter, solenoid valve, pneumatic line, pressure sensor and air inlet.

[0110] FIG. 2E. depicts an exemplary device sensor and switchers positions: for temperature: T1 (temperature on top of the cooling chamber), T2-temperature inside the coolingloop, T3 -temperature on bottom of the cooling chamber, T4 -temperature of the waste chamber. For pressure: Pl (detect the inlet pressure in the system), P2 (built-in the valve, shows the pressure in the filtration unit), For weight: W1 (two sensors working together for the scale), for microswitch: Ml (detect the presence of the waste container), M2 (detect the door closing).

[0111] FIG. 2F. depicts an exemplary device assembly with frame (1), stirrer (2), balance (3), cooling chamber (4), waste container (5), filtration unit (6) being highlighted.

[0112] FIG. 2G shows an exemplary filtration unit connected with waste unit: hole on the bottom part of the filtration unit with the removable tap (1), position of hole for the waste on the support plate below the filtration unit (2), waste-connecting tube is removable and can be sterilized each time before use (3).

[0113] FIG. 2H depicts an exemplary magnetic stirrer: (1) The composition of the stirrer from magnet, belt, 24VDC motor, anti-vibrational feet and ball beaning support. (2) the photo of magnetic stirrer device. (3) The location of the stirring device (2) under the weight-measuring plate (1).

[0114] FIG. 21 depicts an exemplary waste container: scheme of a thermo-regulated system surrounding the waste unit to keep constant temperature inside the waste container (1), photo of the insulation of the thermo-regulated waste unit with fan (2) and photo of the container inside the thermoregulated system (3).

[0115] FIG. 3 depicts exemplary elements of a filtration unit of an enrichment device.

[0116] FIG. 4 depicts an exemplary filtration unit.

[0117] FIG. 4A depicts an exemplary filtration unit: schematic view (1), locker system (3), photo of unit (3) and photo of locker system (4) to lock-unlock the bottom part from the rest of the unit.

[0118] FIG. 4B depicts an exemplary filtration unit 1. main part, 2. lid and 3. bottom (A), position of the filter in the filtration unit and the o-rings before filtration (B), the air filter attachment prior the enrichment to the filtration unit lid (C). FIG. 5A-C depict exemplary elements of a UV measurement head with hole for security LED and locker with magnet for UV- LED enabling. FIG. 5 A depicts the sensor area with magnetic locker and sensor area. FIG.5 B depicts glass cover. FIG. 5 C depicts drop of milk measurement head FIG. 5B depicts the measurement covered by quartz cover prior the measurements.

[0119]

[0120] FIG. 6 depicts an exemplary schematic for a UV measurement head.

[0121] FIG. 7 depicts an exemplary block diagram of an electronic circuit of a UV measurement head.

[0122] FIGS. 8A-8B depict exemplary schematic views for a UV measurement head.

[0123] FIGS. 8A-C depict UV measurement data for various samples and protein and fat content data determined therefrom, in accordance with some embodiments. FIG. 8A depicts a plurality of UV spectra corresponding to various different samples; FIG. 8B depicts absorbance measurements for various different samples after application of a processing filter; FIG. 8C depicts (i) a plot showing correspondence between protein content as determined using a UV measurement head as disclosed herein versus as determined using MIR spectroscopy, and (ii) a plot showing correspondence between fat content as determined using a UV measurement head as disclosed herein versus as determined using MIR spectroscopy. FIG. 8D depicts absorbance measurements after applying the SavGol filter (for the data shown in Fig. A.), so called preprocessing step. The pre-processed spectra for ten different samples are shown (from SO to S9, with different protein and fat concentrations, concentrations are shown in brackets in g / lOOml, first number. FIG. 8E depicts the accuracy of the measurement of protein (A) and fat (B) concentrations (in g / lOOml) as measured by the UV-spectroscopy with our novel UV- measurment head (OY axis) versus the same samples, measured by MIR-middle infrared spectorscopy (using commercial device acquired from Miris AB) (OX axis).DETAILED DESCRIPTION

[0124] The following description sets forth exemplary methods, parameters and the like. It should be recognized, however, that such description is not intended as a limitation on the scope of the present disclosure but is instead provided as a description of exemplary embodiments.

[0125] The present invention provides an easy-to-use system and an easily performed method which allows for the production of a fat- and protein-enriched fraction of breast milk even by persons without laboratory technical knowledge, in particular by mothers and nurses. The present invention makes it possible to control the macronutrient content of fortified milk (in particular with regard to protein content and / or fat content), with a view to optimize nutrition of preterm infants.

[0126] Reference to “unenriched milk” herein refers to milk that has been expressed and has not been delipidated, treated with chemicals, or concentrated. Unenriched milk may be expressed from a mother, a donor, or an animal. In some embodiments, a sample of unenriched milk is obtained from a single individual. “Unenriched milk” may be used synonymously with “crude milk” or “raw milk”. Unenriched milk may be pasteurized or unpasteurized. Preferably, unenriched milk is unpasteurized. As a non-limiting example, unenriched milk may have a carbohydrate content of about 6.1 to about 8.5 g / 100 ml, a fat content of about 0.5 g to about 4.5 g / 100 ml, and / or a protein content of about 0.5 to about 3.0 g / 100 ml. Unenriched milk may be fed to an infant, particularly when the infant does not require fortified milk.

[0127] Reference to “enriched milk” herein refers to milk that has been concentrated such that it has a higher concentration of fat and protein compared to unenriched milk. “Enriched milk” may be used synonymously with “milk fortifier”. Enriched milk produced from unenriched milk obtained from a human may be used synonymously with “human milk origin fortifier” or “HMOF”. Enriched milk may be pasteurized or unpasteurized.

[0128] Reference to “fortified milk” herein refers to a mixture of unenriched milk and enriched milk, wherein the fortified milk has a higher fat and protein content than unenriched milk. Unenriched milk may be fortified by mixing with enriched milk. Enriched milk may be diluted by mixing with unenriched milk. Unenriched milk and enriched milk may be combined in various amounts to access fortified milk having target levels of protein, fat, and / or carbohydrates. As a non-limiting example, fortified milk may have a carbohydrate content of about 6 to about 8 g / 100 ml, a fat content of about 2.5 to about 5.0 g / 100 ml, and a protein content of about 1.5 to about 3.5 g / 100 ml. Fortified milk may be pasteurized or unpasteurized. Fortified milk may be fed to an infant.

[0129] Reference to “about” a value or parameter herein includes (and describes) embodiments that are directed to that value or parameter per se. For example, description referring to “about X” includes description of “X”. In some embodiments, the term “about” when used in association with a measurement, or used to modify a value, a unit, a constant, or a range of values, refers to variations of + / - 10%, 5%, 2%, or 1%.

[0130] Reference to “macronutrients” herein includes fats, proteins, and carbohydrates.

[0131] Reference to “between” two values or parameters herein includes (and describes) embodiments that include those two values or parameters per se. For example, description referring to “between x and y” includes description of “x” and “y” per se.

[0132] The systems and methods as described herein employ a filtration system or process, as illustrated in FIG. 1, to provide human milk origin fortifier compositions. With reference to FIG. 1, an unenriched milk sample (labelled 1 in FIG. 1), such as breast milk pumped from an infant’s own mother or a human donor and has not been delipidated or treated with chemicals, is provided. The unenriched milk sample is passed through a filtration unit comprising a microfilter membrane for the concentration of protein and fat. The ultrafilter separates fat and proteins from the water and small-sized molecules in the milk by preventing the passage of compounds larger than the pore size of the ultrafilter. This ultrafiltration provides a fat- and protein-enriched retentate fraction (labelled 2 in FIG. 1). The retentate after ultrafiltration may be four to ten times less in volume than the initial unfiltered liquid. The retentate fraction is human milk origin fortifier (HMOF) which in some embodiments is given to a neonate after mixing with unenriched human milk at certain ratios based on the individual requirements of the neonate. A filtrate after ultrafiltration (labelled 3 in FIG. 1) passes through the ultrafilter, and comprises water and smallsize molecules. In one variation, positive air pressure may be applied to facilitate the filtration. In one variation, positive air pressure is applied using compressed air (CA in FIG. 2A-C).

[0133] The system of the invention may include a bacterial removal filter, a disposable tube and second air filter, a solenoid valve, a pneumatic line, a pressure sensor and an air inlet (FIG. 2D)

[0134] Several sensors may be present in the system, as shown for example in FIG. 2E. A temperature sensor may be positioned at the top of a cooling chamber. Another temperature sensor may be located inside a cooling loop. Another temperature sensor may be positioned on the bottom of the cooling chamber. A further temperature sensor may be positioned to measure the temperature of a waste chamber.A pressure sensor may be integrated to detect the inlet pressure in the system. Another pressure sensor may be configured to measure the pressure in the filtration unit.

[0135] The system may comprise several weight sensors. The weight sensors may act together, as highlighted in FIG. 2E. In particular, two weight sensors may cooperate to form ascale (Wl). A further weight sensor may detect the presence of waste container (Ml microswitch) and a sensor may detect closing of the door (M2). Certain components of the system are shown in FIG. 2F and may comprise (highlighted in FIG. 2F): frame (A), stirrer (B), balance (C), cooling chamber (D), waste container (E), filtration unit (F).

[0136] In contrast to existing methods used for the preparation of human milk origin fortifiers, the systems and methods of the present disclosure do not require chemical means (e.g., acidification), thermal means e.g., heating), or centrifugation to remove fat from the source human breast milk prior to concentration of the fat and protein. Crude milk without any treatment, other than pasteurization in some instances, may be applied directly to the ultrafilter. This may be referred to as “one-step” enrichment, and it may reduce the total time of enrichment and reduce the complexity of the device.

[0137] In existing large-scale processes, protein fractions and fat fractions are usually enriched by separate protocols. The fat fraction is first separated from the rest of the milk using centrifugation, as it was assumed a filter would immediately be blocked by lipids if enrichment was performed using dead-end filtration. Surprisingly, it has been found by the present inventors that the composition of human milk lipid micelles allows for efficient filtering through a “single- step” ultrafiltration process with certain parameters. In some embodiments, these parameters include a proper stirring regime, filter media that is resistant to nonspecific fat globules and protein precipitation that may prevent further filtration, certain values of air pressure, and / or a specifically constructed bottom plate of a filtration unit with a certain groove size and geometry for liquid evacuation. Unlike certain known systems in which lateral ports are located on a wall of the bottom lid to evacuate liquid, the systems disclosed herein may use an evacuation port on the bottom that is formed as a centered hole. Grooves on the bottom plate may be arranged and oriented to collect the liquids after the disposable filter and direct the liquids to the center hole, where the liquids may evacuate into a small tube. In some embodiments, the efficiency of fat recovery in the enriched milk is 90% or more of the total fat content of the unenriched milk. In some embodiments, the efficiency of protein recovery in the enriched milk is 90% or more of the total protein content of the unenriched milk. In some embodiments, the one-step filtration process allows for milk enrichment through a compact table-top device. In some embodiments, the filtration process is automatic. In some embodiments, the filtration process is autonomous. Insome embodiments, the filtration process is controlled by a computer program associated with an operating system. The computer program may receive data from the sensors. The operating system may regulate the switchers and process parameters based on said data to operate the system, including by automatically controlling one or more physical components of the system (e.g., solenoid valves, pressure pumps, heating devices, etc.).

[0138] The present invention may also be applied to the rearing of animals, including within the framework of zoological breeding programs.I. SYSTEM

[0139] In some aspects, provided is a system configured to enrich unenriched breast milk and quantify an amount of protein and / or fat in unenriched or enriched breast milk, comprising: an enrichment device, configured to obtain a protein and fat enriched fraction from the unenriched breast milk, wherein the enrichment device comprises: a filtration unit comprising an ultrafilter; and a reservoir, wherein the filtration unit is configured to separate a protein and fat enriched retentate from a protein and fat reduced filtrate; a first program comprising a first set of executable instructions configured to control one or more parameters of the enrichment device; a UV measurement head, configured to measure UV absorbance of a sample comprising unenriched or enriched breast milk; and a second program comprising a second set of executable instructions configured to quantify the amount of protein and / or fat in unenriched or enriched breast milk.

[0140] In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to about 200 kDa. In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to about 150 kDa. In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to about 100 kDa. In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to about 50 kDa. In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to about 30 kDa.

[0141] In some embodiments, the filtration unit may be positioned above a stirring device. A hole may be formed in a bottom part of the filtration unit to connect the filtration unit and thewaste container (FIG. 2G). The filtrate can pass from the filtration unit to the waste unit through the hole on the bottom part. The bottom part can have a removable tap (A), needed to close the bottom part when the filtration unit is autoclaved prior use. The tap may be removed when a filter is inserted and prior to the milk being poured inside the unit. The support plate may comprise weight sensors and a magnetic stirring device and has a centered hole, wherein the position of the hole allows to directly connect the filtration unit with a waste container (B). This connection allows waste directly be collected into the container. The filtrate’s contacting tube for the waste collection is removable and can be sterilized each time before use (C).

[0142] In some embodiments the device has a stirring device located under the filtration unit (FIG. 2H) The stirring device may be a magnetic stirring device. The stirring device is configured to mix the milk inside the filtration unit during the enrichment Prior to the enrichment, a magnetic bar may be placed inside the filtration unit with the poured milk. (A) The stirring device comprises a stirrer formed by magnet, belt, 24VDC motor, anti-vibrational feet and a ball beaning support. The stirring device is located under the supporting plate of the filtration unit comprising the weight-measuring sensors (1). The stirring device may operate in a range of about 50 rpm to about 200rpm. A high stirring regime may be used when starting the process. Then, as the volume decreases, stirring speed may be reduced so as to reduce the risk of forming foam. When there is less than about 100 ml inside the filtration unit (e.g., as automatically determined using one or more weight sensors of the system), the system may automatically switch to a lower stirring regime, e.g., about 50 rpm to about 70rpm.

[0143] In some embodiments, the enrichment device further comprises a second reservoir configured to receive the protein and fat reduced filtrate from the filtration unit. In some embodiments the enrichment device further comprises a second reservoir (or so-called waste container) which is located inside the separate cooling chamber (by Peltier technology) (FIG. 21). The waste container remains inside the cooling chamber during enrichment to keep a constant temperature inside the waste container (A). This further allows to administrate the so- called waste fractions (filtrate after first step) for patients for different applications since the filtrate can contain multiple beneficial elements (free amino acids, lactose, HMOs, microRNA etc) which may be not needed for fortification of the food of the preterm neonates but can beuseful for a range of other applications (e.g. HMO are beneficial for gut microbiota for both adults and children).

[0144] In some embodiments, the enrichment device further comprises a weight sensor (FIG. 2D, for weight sensors W1 and W2, and FIG. 2G). In some embodiments, the weight sensor is associated with the filtration unit and is configured to provide a real-time weight reading of the protein and fat enriched retentate or the weight sensor is associated with the second reservoir and is configured to provide a real-time weight reading of the protein and fat reduced filtrate. In some embodiments, the weight sensor is associated with the filtration unit and is configured to provide a real-time weight reading of the protein and fat enriched retentate. In some embodiments, the weight sensor is associated with the second reservoir and is configured to provide a real-time weight reading of the protein and fat reduced filtrate.

[0145] In some embodiments, the weight sensor is associated with the filtration unit and is configured to provide a real-time weight reading of the protein and fat enriched retentate or the weight sensor is associated with the second reservoir and is configured to provide a real-time weight reading of the protein and fat reduced filtrate. In some embodiments, the weight sensor is associated with the filtration unit and is configured to provide a real-time weight reading of the protein and fat enriched retentate. In some embodiments, the weight sensor is associated with the second reservoir and is configured to provide a real-time weight reading of the protein and fat reduced filtrate.

[0146] In some embodiments, the enrichment device further comprises one or more pressure valves connected with the filtration unit. In some embodiments, the enrichment device further comprises one or more pressure valves connected with the filtration unit, wherein one or more pressure valves are configured to provide a positive air pressure to the filtration unit. In some embodiments, the enrichment device further comprises one pressure valve connected with the filtration unit, wherein the pressure valve is configured to provide a positive air pressure to the filtration unit. In some embodiments, the enrichment device further comprises two pressure valves connected with the filtration unit, wherein one pressure valve is configured to provide a positive air pressure to the filtration unit. In some embodiments, the enrichment device further comprises one or more pressure sensors integrated with each of the one or more pressure valves.

[0147] The position of these pressure sensors is shown in FIG. 2E (Pl and P2 for pressure sensors). In some embodiments, the enrichment device further comprises one or more pressure sensors integrated with each of the one or more pressure valves, wherein the pressure sensors are configured to monitor the air pressure inside the filtration unit. In some embodiments, one or more pressure valves are configured to release air and decrease an air pressure inside the filtration unit. In some embodiments, a first pressure valve is configured to provide a positive air pressure to the filtration unit, and a second pressure valve is configured to release air and decrease the air pressure inside the filtration unit.

[0148] In some embodiments, the enrichment device can sense the presence or absence of the waste container (Ml) and the door closing (M2) (FIG. 2E). This may facilitate the process of enrichment by the device for a final user and detect any possible error prior to the start of the process.

[0149] In some embodiments, the enrichment device is configured to transmit one or more parameters to one or more processors of the system, e.g., to a first program. In some embodiments, the one or more parameters the enrichment device is configured to transmit are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, a temperature around the waste container, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of the protein and fat reduced filtrate, a position of the door locker (open or closed) for closing the cooling chamber with filtration unit, and a position of the waste container (allocated or missing) inside the waste cooling chamber. In some embodiments, the enrichment device is configured to transmit an air pressure inside the filtration unit. In some embodiments, the enrichment device is configured to transmit a stirring speed inside the filtration unit. In some embodiments, the enrichment device is configured to transmit a temperature around the filtration unit. In some embodiments, the enrichment device is configured to transmit a temperature around the waste container. In some embodiments, the enrichment device is configured to transmit an amount of time that has passed. In some embodiments, the enrichment device is configured to transmit a weight reading of the protein and fat enriched retentate. In some embodiments, the enrichment device is configured to transmit a weight reading of the protein and fat reduced filtrate. In some embodiments, the enrichment device is configured totransmit a position of the door locker (open or closed) for closing the cooling chamber with filtration unit, and a position of the waste container (allocated or missing) inside the waste cooling chamber. In some embodiments, the enrichment device is configured to transmit an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit. In some embodiments, the enrichment device is configured to transmit an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, and a weight reading of the protein and fat enriched retentate. In some embodiments, the enrichment device is configured to transmit an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, a temperature around the waste container, and a weight reading of the protein and fat enriched retentate. In some embodiments, the enrichment device is configured to transmit an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, a temperature around the waste container, and a weight reading of the protein and fat enriched retentate and a position of door locker (open or closed). In some embodiments, the enrichment device is configured to transmit an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, a temperature around the waste container, and a weight reading of the protein and fat enriched retentate. In some embodiments, the enrichment device is configured to transmit an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, a temperature around the waste container, and a weight reading of the protein and fat enriched retentate and a position of door locker (open or closed) and a waste container presence (present or missing). In some embodiments, the enrichment device is configured to transmit an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, and a weight reading of the protein and fat reduced filtrate. Parameters transmitted to the one or more processors may be determined based on one or more sensors that detect a current status or state of one or more components of the system or of material (e.g., air, milk, other fluid) contained therein. Parameters transmitted to the one or more processors may subsequently be used by the one or more processors to automatically and adaptively control operation of the system, for example by automatically controlling operation of one or more system components to adjust a parameter in response to an indication that a parameter is currently outside a target threshold or window.

[0150] In some embodiments, the one or more controllable parameters of the enrichment device are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit. In some embodiments, a controllable parameter of the enrichment device is an air pressure inside the filtration unit. In some embodiments, a controllable parameter of the enrichment device is a stirring speed inside the filtration unit. In some embodiments, a controllable parameter of the enrichment device is a temperature around the filtration unit. In some embodiments, the controllable parameter of the enrichment device is an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit.

[0151] In some embodiments, the first program comprising a first set of executable instructions is configured to change an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and / or a temperature around the filtration unit upon the enrichment device transmitting a particular weight reading of the protein and fat enriched retentate or a particular weight reading of the protein and fat reduced filtrate. In some embodiments, the first program comprising a first set of executable instructions is configured to change an air pressure inside the filtration unit and a stirring speed inside the filtration unit. In some embodiments, the first program comprising a first set of executable instructions is configured to change an air pressure inside the filtration unit and a stirring speed inside the filtration unit upon the enrichment device transmitting a particular weight reading of the protein and fat enriched retentate. In some embodiments, the first program comprising a first set of executable instructions is configured to change an air pressure inside the filtration unit and a stirring speed inside the filtration unit upon the enrichment device transmitting a particular weight reading of the protein and fat reduced filtrate. In some embodiments, the particular weight reading of the protein and fat enriched retentate is about one third of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat reduced filtrate is about two thirds of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat enriched retentate is about one half of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat reduced filtrate is about one half of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat enriched retentate is about one seventh of the original weight of the unenriched milk. In some embodiments, theparticular weight reading of the protein and fat reduced filtrate is about six sevenths of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat enriched retentate is about one ninth of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat reduced filtrate is about eight ninths of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat enriched retentate is about one tenth of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat reduced filtrate is about nine tenths of the original weight of the unenriched milk.

[0152] In some embodiments, weight of the filtrate and / or retentate may be used by the system and / or a user to determine when to stop the filtration process (e.g., when a target weight has been reached). However, the weight of the filtrate and / or retentate may not necessarily indicate an amount of protein and fat in either the filtrate or retentate, as this may vary due to various factors from person to person. After a weight reading is used to determine when to stop the filtration process, then the UV-based measurement process explained herein may be used to quantify concentration of protein and fat in the portion. This quantification may allow for the system and / or a user to make a decision about the manner and / or extent to which the portion is used for dilution. Additionally or alternatively, the system may measure an amount of protein and fat in non-enriched milk; if fat is high before enrichment, then it can be difficult to concentrate, so understanding that fat level can be helpful.

[0153] In some embodiments, the first program is associated with an operating system having a user interface. In some embodiments, the first program is associated with an operating system external to the enrichment unit. In some embodiments, the first program is associated with an operating system incorporated into the enrichment unit. In some embodiments, the first program is associated with an operating system incorporated into the enrichment unit, and the user interface is incorporated into the enrichment unit.

[0154] In some embodiments, the UV measurement head comprises: a LED light source configured to emit UV light; a sample chamber configured to hold the sample; one or morelenses configured to focus the emitted UV light; and a UV spectrometer configured to measure UV absorbance of the sample.

[0155] In some embodiments, the UV measurement head comprises a sample temperature- controlled chamber configured to keep constant temperature around the sample (at room temperature or lower) to prevent or mitigate heating of a sample cuvette by a LED-lamp and prevent or mitigate a signal shift for UV-absorbance that could be caused by heating. In some embodiments, the spectrometer housing may heat up during use and cause thermal drift of the working point of the UV-LED, which would compromise the reliability of the absorbance data obtained. In some embodiments, new reference data may be obtained regularly (e.g., every five minutes) in order to compensate for signal drift of the working point of the UV-LED.

[0156] In some embodiments, the second program is configured to quantify the amount of protein and / or fat in the unenriched or enriched breast milk from the UV absorbance of the sample. In some embodiments, the second program is configured to quantify the amount of protein and fat in the unenriched or enriched breast milk from the UV absorbance of the sample. In some embodiments, the second program is configured to quantify the amount of protein and fat in the unenriched breast milk from the UV absorbance of the sample. In some embodiments, the second program is configured to quantify the amount of protein and fat in the enriched breast milk from the UV absorbance of the sample.

[0157] In some embodiments, the second program is associated with an operating system having a user interface. In some embodiments, the operating system is external to the UV measurement head. In some embodiments, the enrichment device and the UV measurement head are separate units. In some embodiments, the first and second programs are associated with the same operating system. In some embodiments, the first and second programs are associated with the same operating system, and the operating system is external to both devices. In some embodiments, the enrichment device and the UV measurement head are integrated into a single unit. In some embodiments, the first and second programs are associated with the same operating system, and the operating system is internal to the single unit. In some embodiments, the first program is associated with a first operating system integrated into the enrichment device, and thesecond program is associated with a second operating system that is external to the UV measurement head.

[0158] In some embodiments, a sample of unenriched milk is analyzed using the UV measurement head in combination with a program comprising a set of executable instructions for analyzing the sample before the unenriched milk is passed through the enrichment unit. In some embodiments, a sample of enriched milk is analyzed using the UV measurement head in combination with a program comprising a set of executable instructions for analyzing the sample after the enriched milk is produced using the enrichment unit. In some embodiments, unenriched milk that has not been analyzed by UV spectroscopy is passed through the enrichment unit, then a sample of the resulting enriched milk is analyzed using the UV measurement head in combination with a program comprising a set of executable instructions for analyzing the sample. In some embodiments, a sample of unenriched milk is analyzed using the UV measurement head in combination with a program comprising a set of executable instructions for analyzing the sample, then the resulting enriched milk is not analyzed by UV spectroscopy. In some embodiments, a sample of unenriched milk is analyzed using the UV measurement head in combination with a program comprising a set of executable instructions for analyzing the sample, then the unenriched milk is passed through the enrichment device, then a sample of the resulting enriched milk is analyzed using the UV measurement head in combination with a program comprising a set of executable instructions for analyzing the sample.

[0159] In some embodiments, the enrichment process is completed before the resulting enriched milk is analyzed. In some embodiments, the enrichment process is not interrupted to use the UV measurement head to analyze partially enriched milk. In some embodiments, interrupting the enrichment process to analyze partially enriched milk is unhygienic. In some embodiments, the UV measurement head and the enrichment device are connected to two separate operating systems. In some embodiments, the UV measurement head and the enrichment device are not physically connected. In some embodiments, a human operator manually operates the UV measurement head and the enrichment device separately.

[0160] In some embodiments, partially enriched milk is analyzed using the UV measurement head after the enrichment process begins and before the enrichment process is complete. In someembodiments, the UV measurement head is used to analyze partially enriched milk in real time during the enrichment process. In some embodiments, the UV measurement head and the enrichment device are connected to one operating system. In some embodiments, the UV measurement head and the enrichment device are incorporated into one combined unit. In some embodiments, analysis of milk during the enrichment process is used to determine whether the enrichment process should be ceased. The system may automatically determine (or the user may determine based on information displayed by the system) whether a current enrichment level of the milk meets target enrichment levels. In the event that target enrichment levels are met, then the enrichment process may be ceased. It should be noted that UV analysis may be required to accurately quantify fat and protein levels for the purpose of quantifying enrichment, rather than relying solely on weight measurements, because total concentration of protein and fat in breast milk is highly variable from person to person and depends on many factors. In some embodiments, in addition to or alternatively to informing a decision about when to stop enrichment or dilution, a quantification of protein and fat content in unenriched milk may also be used to determine whether target enrichment levels can (or cannot) be achieved. In some embodiments, in addition to or alternatively to informing a decision about when to stop enrichment or dilution, a quantification of protein and fat content in unenriched milk may also be used to meet so-called personalized nutrition when optimal fortification regime is introduced based on individual and daily variations of macronutritnets in human milk. In this case, for example, the novel UV head disclosed herein can act as an independent device as a human milk analyzer.

[0161] In some aspects, provided is a method for enriching breast milk and quantifying an amount of protein and / or fat in unenriched or enriched breast milk, comprising: passing a sample of unenriched milk through a filtration unit comprising a filter; collecting a sample of enriched milk from a protein and fat enriched retentate; illuminating at least one of a sample comprising unenriched milk and a sample comprising enriched milk; measuring UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk, wherein the UV absorbance is measured using a UV measurement head; and quantifying an amount of protein and / or fat in said at least one of said sample comprising unenriched milk and said sample comprising enriched milk using said UV absorbance.

[0162] In some embodiments, the method comprises illuminating a sample comprising unenriched milk, measuring UV absorbance of said sample, and quantifying an amount of protein and / or fat in said sample. In some embodiments, the method comprises illuminating a sample comprising unenriched milk, measuring UV absorbance of said sample, and quantifying an amount of protein in said sample. In some embodiments, the method comprises illuminating a sample comprising unenriched milk, measuring UV absorbance of said sample, and quantifying an amount of protein fat in said sample. In some embodiments, the method comprises illuminating a sample comprising unenriched milk, measuring UV absorbance of said sample, and quantifying an amount of protein and fat in said sample. In some embodiments, the method comprises illuminating a sample comprising enriched milk, measuring UV absorbance of said sample, and quantifying an amount of protein and / or fat in said sample. In some embodiments, the method comprises illuminating a sample comprising enriched milk, measuring UV absorbance of said sample, and quantifying an amount of protein in said sample. In some embodiments, the method comprises illuminating a sample comprising enriched milk, measuring UV absorbance of said sample, and quantifying an amount of protein fat in said sample. In some embodiments, the method comprises illuminating a sample comprising enriched milk, measuring UV absorbance of said sample, and quantifying an amount of protein and fat in said sample. In some embodiments, the method comprises illuminating a first sample comprising unenriched milk, measuring UV absorbance of said first sample, illuminating a second sample comprising enriched milk, measuring UV absorbance of said second sample, and quantifying an amount of protein and / or fat in said samples. In some embodiments, the method comprises illuminating a first sample comprising unenriched milk, measuring UV absorbance of said first sample, illuminating a second sample comprising enriched milk, measuring UV absorbance of said second sample, and quantifying an amount of protein in said sample. In some embodiments, the method comprises illuminating a first sample comprising unenriched milk, measuring UV absorbance of said first sample, illuminating a second sample comprising enriched milk, measuring UV absorbance of said second sample, and quantifying an amount of protein fat in said sample. In some embodiments, the method comprises illuminating a first sample comprising unenriched milk, measuring UV absorbance of said first sample, illuminating a second sample comprising enriched milk, measuring UV absorbance of said second sample, and quantifying an amount of protein and fat in said sample.

[0163] In some embodiments, the method further comprises illuminating an unenriched milk sample, measuring UV absorbance of said unenriched milk sample, and quantifying an amount of protein and / or fat in said unenriched milk sample using said UV absorbance. In some embodiments, the method further comprises illuminating an unenriched milk sample, measuring UV absorbance of said unenriched milk sample, and quantifying an amount of protein and fat in said unenriched milk sample using said UV absorbance. In some embodiments, the method comprises illuminating an enriched milk sample, measuring UV absorbance of said enriched milk sample, and quantifying an amount of protein and / or fat in said enriched milk sample using said UV absorbance. In some embodiments, the method comprises illuminating an enriched milk sample, measuring UV absorbance of said enriched milk sample, and quantifying an amount of protein and fat in said enriched milk sample using said UV absorbance. In some embodiments, the method comprises illuminating an unenriched milk sample, measuring a first UV absorbance wherein the first UV absorbance is the absorbance of said unenriched milk sample, quantifying an amount of protein and / or fat in said unenriched milk sample using said first UV absorbance, illuminating an enriched milk sample, measuring a second UV absorbance wherein the second UV absorbance is the absorbance of said enriched milk sample, and quantifying an amount of protein and / or fat in said enriched milk sample using said second UV absorbance. In some embodiments, the method comprises illuminating an unenriched milk sample, measuring a first UV absorbance wherein the first UV absorbance is the absorbance of said unenriched milk sample, quantifying an amount of protein and fat in said unenriched milk sample using said first UV absorbance, illuminating an enriched milk sample, measuring a second UV absorbance wherein the second UV absorbance is the absorbance of said enriched milk sample, and quantifying an amount of protein and fat in said enriched milk sample using said second UV absorbance.

[0164] In some embodiments, the method further comprising monitoring one or more filtration parameters while passing the sample of unenriched milk through the filter. In some embodiments, the method comprises monitoring one or more filtration parameters selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of a protein and fat reduced filtrate. In some embodiments, the method comprises monitoring an air pressure insidethe filtration unit. In some embodiments, the method comprises monitoring a stirring speed inside the filtration unit. In some embodiments, the method comprises monitoring a temperature around the filtration unit. In some embodiments, the method comprises monitoring an amount of time that has passed. In some embodiments, the method comprises monitoring a weight reading of the protein and fat enriched retentate. In some embodiments, the method comprises monitoring a weight reading of a protein and fat reduced filtrate. In some embodiments, the method comprises monitoring an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit. In some embodiments, the method comprises monitoring an air pressure inside the filtration unit and a stirring speed inside the filtration unit. In some embodiments, the method comprises monitoring an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a weight reading of the protein and fat enriched retentate. In some embodiments, the method comprises monitoring an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a weight reading of a protein and fat reduced filtrate.

[0165] In some embodiments, one or more filtration parameters are monitored using a first program comprising a first set of executable instructions. In some embodiments, the first program comprising a first set of executable instructions is configured to control one or more filtration parameters selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit. In some embodiments, the first program comprising a first set of executable instructions is configured to control an air pressure inside the filtration unit. In some embodiments, the first program comprising a first set of executable instructions is configured to control a stirring speed inside the filtration unit. In some embodiments, the first program comprising a first set of executable instructions is configured to control a temperature around the filtration unit. In some embodiments, the first program comprising a first set of executable instructions is configured to control an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit. In some embodiments, the first program is associated with an operating system having a user interface.

[0166] In some embodiments, the method further comprises homogenizing the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenrichedbreast milk, and / or the sample comprising enriched breast milk. In some embodiments, the method further comprises homogenizing the sample of unenriched breast milk. In some embodiments, the method further comprises homogenizing the sample of enriched breast milk. In some embodiments, the method further comprises homogenizing the sample comprising unenriched breast milk. In some embodiments, the method further comprises homogenizing the sample comprising enriched breast milk.

[0167] In some embodiments, the method further comprises breaking large micelles and aggregates in the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk. In some embodiments, the method further comprises breaking large micelles and aggregates in the sample of unenriched breast milk. In some embodiments, the method further comprises breaking large micelles and aggregates in the sample of enriched breast milk. In some embodiments, the method further comprises breaking large micelles and aggregates in the sample comprising unenriched breast milk. In some embodiments, the method further comprises breaking large micelles and aggregates in the sample comprising enriched breast milk.

[0168] In some embodiments, the UV measurement head is configured to transmit the UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk to a second program comprising a second set of executable instructions configured to quantify the amount of protein and / or fat in the at least one sample comprising unenriched milk or said sample comprising enriched milk. In some embodiments, the UV measurement head is configured to transmit the UV absorbance of a sample comprising unenriched milk to a second program comprising a second set of executable instructions configured to quantify the amount of protein and / or fat in the sample comprising unenriched milk. In some embodiments, the UV measurement head is configured to transmit the UV absorbance of a sample comprising enriched milk to a second program comprising a second set of executable instructions configured to quantify the amount of protein and / or fat in the sample comprising enriched milk. In some embodiments, the UV measurement head is configured to transmit the UV absorbance of said at least one said sample comprising unenriched milk and said sample comprising enriched milk to a second program comprising a second set of executable instructions configured to quantify the amount of protein and / or fat in the at least one samplecomprising unenriched milk or said sample comprising enriched milk. In some embodiments, the UV measurement head is configured to transmit the UV absorbance of a sample comprising unenriched milk to a second program comprising a second set of executable instructions configured to quantify the amount of protein and / or fat in the sample comprising unenriched milk. In some embodiments, the UV measurement head is configured to transmit the UV absorbance of a sample comprising enriched milk to a second program comprising a second set of executable instructions configured to quantify the amount of protein and / or fat in the sample comprising enriched milk. In some embodiments, the second program is associated with an operating system having a user interface. In some embodiments, the operating system is external to the UV measurement head.

[0169] In some embodiments, one or more filtration parameters are monitored using a first program comprising a first set of executable instructions, the UV measurement head is configured to transmit the UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk to a second program comprising a second set of executable instructions configured to quantify the amount of protein and / or fat in the at least one sample comprising unenriched milk or said sample comprising enriched milk, and the first program and the second program are associated with the same operating system. In some embodiments, the method further comprises converting the UV absorbance of the sample comprising unenriched milk or the sample comprising enriched milk into a UV absorbance spectrum. In some embodiments, the method further comprises comparing the UV absorbance spectrum with a reference curve that is a UV absorbance spectrum of water or air. In some embodiments, the reference curve is a UV absorbance spectrum of water. In some embodiments, the reference curve is a UV absorbance spectrum of air.

[0170] In one example, a system provided herein may predict what the maximum allowed reduction volume for milk can be. For example, if an initial fat concentration 3.0g / 100ml is determined (e.g., based on UV measurement as described herein of the un enriched sample), then the system may automatically determine that a final reduction factor of xlO would not be possible, as a fat concentration of 30g / 100ml would be too high and the fortifier would not be recoverable. Thus, id a user executes an input to a user interface of the system indicating adesired xlO reduction for the initial sample, then the system may generate an alert to be displayed to the user and may prevent the system from beginning enrichment.II. UV MEASUREMENT HEAD DEVICE

[0171] In some aspects, provided is a device that is a UV measurement head for quantifying the amount of protein and / or fat in a sample, wherein the sample comprises unenriched or enriched breast milk, wherein the device comprises: a LED light source configured to emit UV light; a sample chamber configured to hold the sample; one or more lens configured to focus the emitted UV light; and a UV spectrometer configured to measure UV absorbance of the sample.

[0172] In some embodiments, the sample comprises unenriched breast milk. In some embodiments, the sample comprises enriched breast milk. In some embodiments, the UV measurement head is for quantifying the amount of protein in a sample. In some embodiments, the UV measurement head is for quantifying the amount of fat in a sample. In some embodiments, the UV measurement head is for quantifying the amount of protein and fat in a sample. In some embodiments, the UV spectrometer is calibrated using water or air. In some embodiments, the UV spectrometer is calibrated using water. In some embodiments, the UV spectrometer is calibrated using air.

[0173] In some embodiments, the sample chamber is a cuvette comprising a cuvette cover. In some embodiments, the sample chamber is a cuvette comprising a cuvette bottom. In some embodiments, the sample chamber is a cuvette comprising a cuvette cover and a cuvette bottom. In some embodiments, the cuvette cover and cuvette bottom each comprise quartz -glass. In some embodiments, the cuvette cover and cuvette bottom are separated by less than or equal to about 0.5 mm or less than or equal to about 0.2 mm when the sample chamber is closed, the cuvette cover and cuvette bottom are separated by less than or equal to about 0.5 mm when the sample chamber is closed. In some embodiments, the cuvette cover and cuvette bottom are separated by less than or equal to about 0.2 mm when the sample chamber is closed.

[0174] In some embodiments, the device is powered by a battery. In some embodiments, the battery is a Li-ion battery. In some embodiments, the battery is charged using a USB connection.In some embodiments, the device is powered using a USB connection. In some embodiments, the device is powered using a USB connection to an operating system.

[0175] In some embodiment, the device is configured to sense an intensity of light indicative of UV absorbance of the sample (e.g., an amount of transmitted light and / or an amount of reflected light) and to generate data indicative of the UV absorbance based on said sensed intensity. (Absorbance may be measured as an intensity, e.g., intensity counts, e.g., as provided by an Ocean Optics spectrometer.) In some embodiments, the device is configured to transmit data indicating the UV absorbance of the sample to a program comprising a set of executable instructions for converting the UV absorbance at different wavelengths of the sample to a UV absorbance spectrum at certain wavelength region. In some embodiments, the device is configured to transmit the UV absorbance of the sample to a program comprising a set of executable instructions for quantifying the amount of protein and / or fat in the sample from the UV absorbance of the sample. In some embodiments, the device is configured to transmit the UV absorbance of the sample to a program comprising a set of executable instructions for quantifying the amount of protein in the sample from the UV absorbance of the sample. In some embodiments, the device is configured to transmit the UV absorbance of the sample to a program comprising a set of executable instructions for quantifying the amount of fat in the sample from the UV absorbance of the sample. In some embodiments, the device is configured to transmit the UV absorbance of the sample to a program comprising a set of executable instructions for quantifying the amount of protein and fat in the sample from the UV absorbance of the sample. In some embodiments, the program is configured to calculate a total energy value of the sample from the quantified amount of protein and fat and an amount (e.g., an estimated amount and / or a modeled amount) of carbohydrates in the sample.

[0176] In some embodiments, the device further comprises a magnetic safety locker and a lid. The lid and magnetic safety locker may operate to prevent the lid from opening when the LED light source is in an operative (“on”) state, thus preventing inadvertent eye damage. In some embodiments, an alternative or additional device to monitor a state of the lid may be used, for example an IR sensor that senses whether the lid is in an open or closed state and controls operation of the LED light source accordingly. In some embodiments, the lid comprises the LED light source. In some embodiments, a program comprising a set of executable instructions isconfigured to prevent the LED light source from emitting UV light when the lid is open. In some embodiments, the program is associated with an operating system having a user interface.

[0177] In some aspects, provided is a UV-spectroscopy-based device to measure protein and fat content in milk. In some aspects, provided is a UV measurement head device used in combination with a computer program to measure protein and fat content in HMOF. In some embodiments, the UV measurement head device used in combination with a computer program measures protein and fat content in unenriched milk. In some embodiments, the UV measurement head device has a relatively low cost.

[0178] With reference to FIG. 5, a UV measurement head comprises a magnetic safety locker (A), a glass cover (B), and a cuvette (C).

[0179] With reference to FIG. 6, a UV spectrometer 2 is held on a metal support piece 1. Above the spectrometer, a lens 3 is held on a lens support piece 4. The spectrometer, lens, and lens support piece are held between two metal support pieces 1 and 5. A milk sample may be placed between two glass plates 6. The top glass plate is held in place by a glass support piece 7 which may be screwed onto or placed onto metal piece 5. The lid of the UV measurement head comprises a support piece 8, a printed circuit board 9 comprising LED lights, spacers 10, and a plexiglass cover 11. The lid of the UV measurement head is attached to support piece 8 and secured with a magnet 12 before measurements are taken.

[0180] With reference to FIG. 8A, the UV measurement head comprises a lid (1) comprising a UV light source, (2) a cuvette cover, and (3) a body, and (4) a spectrometer. FIG. 8B depicts a UV measurement head wherein the lid is closed.

[0181] In some embodiments, the UV measurement head is equal to or less than about 30 cm in length, width, and height. In some embodiments, the UV measurement head is equal to or less than about 20 cm in length, width, and height. In some embodiments, the UV measurement head is equal to or less than about 10 cm in length, width, and height. In some embodiments, the UV measurement head is equal to or less than about 5 cm in length, width, and height. In some embodiments, the UV measurement head is equal to or less than about 3 cm in length, width, and height.

[0182] In some embodiments, the UV measurement head device is connected to a program associated with an operating system, wherein the program models carbohydrate content. In some embodiments, the UV measurement head device is connected to a program associated with an operating system, wherein the program models total carbohydrate content. In some embodiments, the UV measurement head device is connected to a program associated with an operating system, wherein the program uses constant values for carbohydrates. In some embodiments, the UV measurement head device is connected to a program associated with an operating system, wherein the program models total carbohydrate and predicts total energy content. In some embodiments, the UV measurement head device is connected to a program associated with an operating system, wherein the program predicts total energy content using experimental data for fat and protein content and modelled predictions for carbohydrate content. In some embodiments, the obtained information regarding macronutrient content and total energy value can be used to inform decisions for balanced nutrition of a neonate. In some embodiments, the obtained information regarding macronutrient content and total energy value can be used for personalized precise nutrition.

[0183] In some aspects, use of the device is simplified as compared to use of near- or middle-infrared spectroscopy, as used in the current state of the art. In some embodiments, the device is up to five times less expensive than an IR-based device. In some embodiments, use of the device does not require sonication of a milk sample. In some embodiments, use of the device does not require a referencing step, a special buffer, or calibration measurements. In some embodiments, the device does not require a complex cleaning procedure. In some embodiments, a referencing step can be performed in air prior to use of the device. In some embodiments, the device does not require special solutions for referencing. In some embodiments, the device does not require special solutions for calibrating. In some embodiments, the device does not require special solutions for cleaning. In some embodiments, the device simplifies the procedure for analyzing the content of the milk. In some embodiments, the UV measurement head can be used in lower- or middle-income countries to allow for individual fortification of food for a preterm neonate.

[0184] In some embodiments, sonication and / or heating of breast milk samples may not be required for use in the systems disclosed herein. In known methods that rely on middle-infrared (MIR) spectroscopy, the wavelength region from about 2.5 to 25 nm may be used.

[0185] Using the MIR wavelength range requires homogenization of breast milk samples by sonication, in which ultrasonic waves generate a homogenizing effect by cavitation. For example, a sonication may apply energy output at approximately 20 J / sec per ml of human milk to break globules in the milk. In MIR-based systems, a 5.7 pm wavelength region is used for fat determination. If large fat globules are not broken, then a signal cannot be effectively obtained at this wavelength range. Thus, sonication is required to break fat globules in MIR-based systems, while it is not required in the UV-range systems disclosed herein (e.g., those relying on wavelength ranges at approximately 200-350 nm).

[0186] Using the MIR wavelength range requires preheating of breast milk samples to a temperature range of about 39 to 41 °C. This is required to better homogenize the samples, making the milk fat liquid, as the melting temperature of most of the fat molecules in human milk is above 37 °C. In contrast, the use of the UV-based systems disclosed herein do not require a preheating step, as the same results were demonstrated for heated and room temperature samples. For example, the systems described herein using UV-based measurement may work well for samples at room temperature, e.g., 18-25 °C. Samples may be used that are at a temperature of equal to or less than 18, 20, 22, or 25 °C. Furthermore, in some embodiments, for UV spectroscopy, lower temperature of the sample improves sharpness of the signal peaks.

[0187] In some aspects, the UV measurement head used in combination with a computer program measures the fat and protein concentration of unenriched milk. In some aspects, the UV measurement head used in combination with a computer program measures the fat and protein concentration of enriched milk. In some embodiments, the UV measurement head is used jointly with the enrichment device described herein. In some embodiments, the UV measurement head used in combination with a computer program is used to evaluate the total time of the enrichment process. In some embodiments, the UV measurement head used in combination with a computer program is used to evaluate the total time of the enrichment process based on the quantity or concentration of fat in unenriched milk. In some embodiments, for some filter types with certainpore sizes (e.g., 30 kDa), made from PES and cut to the diameter of 80mm at temperature 4C, initial pressure of 4 bars and initial stirring rate of 200 rpm may be used. In some embodiments, a prediction of flow rate may be made for certain initial values of milk protein and fat concentrations. For example, for milk with concentrations l.Og / lOOml protein and 2.0g / 100ml fat, the flow rate first hour may be 30ml / hour, and then 25ml / h, etc. Then, for different combinations of fat and protein, these predicted flow rates may be identified and total time may be estimated, based on initial volume, final volume, and initial concentrations of these two macronutrients. For example, for 500ml of milk to be concentrated to 70ml with above mentioned concentrations, 40 hours may be required. For less fat, it should be faster. In some embodiments, the system may be configured such that the software may automatically make these determinations and configure the system to operate accordingly (e.g., for the required amount of time) based on user inputs regarding the desired reduction and / or based on UV measurement and automatic determination of concentrations in the initial sample.

[0188] In some embodiments, the UV measurement head used in combination with a computer program is used to evaluate the desired volume reduction of the unenriched milk during the enrichment process. In some embodiments, the desired volume reduction is the maximal possible volume reduction. As a non-limiting example, if the UV measurement head used in combination with a computer program indicates the concentration of fat in unenriched milk is equal to or higher than about 3 g / 100 ml, the operator (or the system, automatically) may concentrate the unenriched milk by a factor of about 5 to about 7. As a second non-limiting example, if the UV measurement head used in combination with a computer program indicates the concentration of fat in unenriched milk is equal to or less than about 3 g / 100 ml, the operator (or the system, automatically) may concentrate the unenriched milk by a factor of about 5 to about 10.

[0189] In some embodiments, the UV measurement head is used in combination with an external operating system with a user interface. In some embodiments, the external operating system comprises a program that models the carbohydrate content in the unenriched and / or enriched milk. In some embodiments, the carbohydrate content is modelled based on constant values known from literature data. In some embodiments, the carbohydrate content is modelled based on constant values known from literature data for milk at different lactation stages. Insome embodiments, the carbohydrate content is modelled based on constant values known from literature data for milk from different types of preterm and term neonates (e.g. extremely low- birth weight, very-low birth weight, and low birth weight babies).

[0190] In some embodiments, the predicted values for carbohydrates range from about 7 g / 100 ml to about 8 g / 100 ml. In some embodiments, the predicted values for carbohydrates are around 7 g / 100 ml when the mother or donor is in early stages of lactation or colostrum. In some embodiments, the predicted values for carbohydrates are about 8 g / 100 ml when the lactation of the mother or donor has stabilized. In some embodiments, total carbohydrate content is predicted based on lactose and human milk oligosaccharides (HMO). In some embodiments, the ratio of lactose and HMO varies depending on the stage of lactation of the mother or donor. In some embodiments, the ratio of lactose to HMO is higher in early stages of lactation and lower in later stages of lactation. In some embodiments, the total carbohydrate content is modelled. In some embodiments, the total carbohydrate content of the non-enriched milk is modelled using a constant value. In some embodiments, the total carbohydrate content of the non-enriched milk is modelled using a constant value of about 7.0 g / 100 ml as determined by literature data. In some embodiments, the total carbohydrate content of the enriched milk is modelled using a constant value of about 6.0 to about 6.5 g / 100 ml as determined by experimental data.

[0191] In some embodiments, the computer program is used to calculate total energy values of unenriched and / or enriched milk. In some embodiments, the total energy values are calculated using computer-based predictions. In some embodiments, the computer-based predictions are calculated using the fat and protein concentrations obtained from the UV measurement head used in combination with a computer program and the predicted constant values for carbohydrates.

[0192] In some embodiments, the UV measurement head measurement is based on UV absorption in the range of about 270 nm to about 320 nm. In some embodiments, a light source (e.g., an LED light source) of the UV measurement head generated and / or emits light at or about 280 nm, e.g., in the range of about 270 nm to about 320 nm. In some embodiments, the UV measurement head comprises a UV spectrometer. In some embodiments, the UV spectrometer captures signal indicative of an amount of light that is transmitted by the sample being analyzed,and the system processes the signal, for example using a Partial Least Square (PLS) method. In some embodiments, the UV spectrometer is equal to or less than about 45 mm in width and length, and equal to or less than about 30 mm in height. In some embodiments, the UV measurement head comprises a cuvette. In some embodiments, the cuvette holds a sample comprising liquid milk. In some embodiments, the sample comprises enriched milk. In some embodiments, the sample comprises unenriched milk.

[0193] In some embodiments, the UV spectrometer is calibrated prior to measuring a milk sample. In some embodiments, the UV spectrometer is calibrated with air. In some embodiments, the UV spectrometer is calibrated without a sample in the cuvette. In some embodiments, the calibration is required to write a reference curve before initiating measurements of the milk sample. In some embodiments, the UV spectrometer is calibrated with water. In some embodiments, the UV spectrometer is calibrated with water in the cuvette. In some embodiments, the UV spectrometer is calibrated after about 20 pl of water are dropped gently into the cuvette using a pipette.

[0194] In some embodiments, a glass cover is applied to close the cuvette. In some embodiments, a glass cover is applied to squeeze the milk sample between the two plates. In some embodiments, a glass cover is applied to squeeze the milk sample between the two plates and close the cuvette.

[0195] In some embodiments, UV illumination is applied to illuminate the milk sample. In some embodiments, a LED lamp is used to illuminate the sample. In some embodiments, the LED lamp has a dome lens. In some embodiments, the LED lamp is UVR280-SC3P. In some embodiments, UV illumination provides sufficient sample illumination to achieve a strong UV absorbance signal. In some embodiments, a sample of liquid milk is confined between two plates. In some embodiments, the plates are quartz -glass. In some embodiments, the two plates have a spacer that is about 0.5 mm thick. In some embodiments, the two plates are about 0.5 mm apart. In some embodiments, the two plates are about 0.1 to about 1 mm apart. In some embodiments, a smaller distance between the two plates correlates with a stronger UV signal. In some embodiments, the emitted UV illumination that is transmitted through the sample is focused by a collimating lens. In some embodiments, the emitted UV illumination that istransmitted through the sample is focused by a collimating lens. In some embodiments, signal saturation is reached with about 50 ms of integration time. In some embodiments, signal saturation is reached with about 1 s of integration time. In some embodiments, signal saturation is reached with about 50 ms to about 1 s of integration time.

[0196] In some embodiments, the UV measurement head does not require an external power supply. In some embodiments, the UV measurement head is powered using a battery. In some embodiments, the battery is a Li-ion battery. In some embodiments, the battery is a 1.45 Ah, Jauch Quartz battery. In some embodiments, the battery can be charged through a USB connection. In some embodiments, the UV measurement head is powered through a USB connection to an operating system.

[0197] In some embodiments, the UV measurement head comprises a safety locker. In some embodiments, the safety locker prevents the UV measurement head from delivering UV illumination when the lid is open. In some embodiments, the safety locker protects the eye or eyes of the operator. In some embodiments, the safety locker prevents eye damage to the operator.

[0198] In some embodiments, the distance between the two plates is about 200 pm before the cover is applied. A distance between the plates of 200 pm may be well-suited for transillumination of human milk samples with light sources and sensors as described herein, enabling a compact system with batter powered illumination and with compact UV spectrometer detection. The distance between the two plates / windows of the cuvette may be well defined by precision drilling the cuvette cover and the sensor body. In some embodiments, the cuvette enables simple handling. In some embodiments, the cuvette enables simple cleaning. In some embodiments, the cuvette does not require special tools. In some embodiments, the cuvette does not require special cleaning products. In some embodiments, the cuvette with the sample liquid or reference, the focusing lens, and the entrance slit of the spectrometer are aligned perpendicularly. In some embodiments, this design avoids the requirement for optical fibers for light transport.

[0199] In some embodiments, a sample of enriched milk or unenriched milk is defrosted prior to being placed in the cuvette. In some embodiments, the sample is placed in the cuvetteafter reaching room temperature. In some embodiments, the sample is homogenized before being placed in the cuvette. In some embodiments, the sample is homogenized using a vortex mixer. In some embodiments, the sample is homogenized using a vortex mixer for about 15 to about 30 seconds. In some embodiments, the sample is homogenized using a vortex mixer at about 100 to about 200 rpm. In some embodiments, the sample is homogenized using a vortex mixer at 100 to 200 rpm. In some embodiments, mixing the sample reduces the size of the fat globules. In some embodiments, reducing the size of the fat globules is essential for an accurate measurement.

[0200] In some embodiments, the milk sample is diluted to avoid signal saturation. In some embodiments, the milk sample is diluted with water. In some embodiments, the milk sample is diluted with water by a factor of about 3 to a factor of about 10. In some embodiments, the milk sample is diluted to about 1 :9 milk:water. In some embodiments, HMOF may be diluted. In some embodiments, for non-concentrated milk, there may be no need to dilute. In some embodiments, dilution may be performed before vortexing and before being placed in the cuvette.

[0201] In some embodiments, the UV measurement head may be used to quantify the amount of protein and / or fat in a sample comprising fortified milk. In some embodiments, the UV measurement head is configured to quantify the amount of protein and / or fat in a sample comprising fortified milk. In some embodiments, the UV measurement head is configured to quantify the amount of protein and fat in a sample comprising fortified milk.

[0202] In some aspects, provided is a method for quantifying an amount of protein and / or fat in unenriched or enriched breast milk, comprising: illuminating at least one of a sample comprising unenriched milk and a sample comprising enriched milk; measuring UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk, wherein the UV absorbance is measured using a UV measurement head; and quantifying an amount of protein and / or fat in said at least one of said sample comprising unenriched milk and said sample comprising enriched milk using said UV absorbance.

[0203] In some embodiments, provided is a method for quantifying an amount of protein and / or fat in unenriched or enriched breast milk. In some embodiments, provided is a method for quantifying an amount of protein in unenriched or enriched breast milk. In some embodiments,provided is a method for quantifying an amount of fat in unenriched or enriched breast milk. In some embodiments, provided is a method for quantifying an amount of protein and fat in unenriched or enriched breast milk. In some embodiments, provided is a method for quantifying an amount of protein and fat in unenriched breast milk. In some embodiments, provided is a method for quantifying an amount of protein and fat in enriched breast milk.

[0204] In some embodiments, the method comprises illuminating a sample comprising unenriched breast milk, measuring UV absorbance of said sample, wherein the UV absorbance is measured using a UV measurement head, and quantifying an amount of protein and / or fat in said sample. In some embodiments, the method comprises illuminating a sample comprising unenriched breast milk, measuring UV absorbance of said sample, wherein the UV absorbance is measured using a UV measurement head, and quantifying an amount of protein and fat in said sample. In some embodiments, the method comprises illuminating a sample comprising enriched breast milk, measuring UV absorbance of said sample, wherein the UV absorbance is measured using a UV measurement head, and quantifying an amount of protein and / or fat in said sample. In some embodiments, the method comprises illuminating a sample comprising enriched breast milk, measuring UV absorbance of said sample, wherein the UV absorbance is measured using a UV measurement head, and quantifying an amount of protein and fat in said sample.

[0205] In some embodiments, the method further comprises diluting the sample of unenriched breast milk or the sample of enriched breast milk with water to obtain the sample comprising unenriched breast milk or the sample comprising enriched breast milk. In some embodiments, the method further comprises diluting the sample of unenriched breast milk to obtain the sample comprising unenriched breast milk. In some embodiments, the method further comprises diluting the sample of enriched breast milk to obtain the sample comprising enriched breast milk. In some embodiments, the method comprises diluting the sample of unenriched breast milk or the sample of enriched breast milk with water by about a factor of 10.

[0206] In some embodiments, the method further comprises homogenizing the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk. In some embodiments, the method further comprises homogenizing the sample of unenriched breast milk. In some embodiments,the method further comprises homogenizing the sample of enriched breast milk. In some embodiments, the method further comprises homogenizing the sample comprising unenriched breast milk. In some embodiments, the method further comprises homogenizing sample comprising enriched breast milk.

[0207] In some embodiments, the method further comprises breaking large micelles (e.g., by vortexing) and aggregates in the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk. In some embodiments, the method further comprises breaking large micelles and aggregates in the sample of unenriched breast milk. In some embodiments, the method further comprises breaking large micelles and aggregates in the sample of enriched breast milk. In some embodiments, the method further comprises breaking large micelles and aggregates in the sample comprising unenriched breast milk. In some embodiments, the method further comprises breaking large micelles and aggregates in the sample comprising enriched breast milk.

[0208] In some embodiments, the UV measurement head is configured to transmit the UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk to a program comprising a set of executable instructions configured to quantify the amount of protein and / or fat in the at least one sample comprising unenriched milk or said sample comprising enriched milk. In some embodiments, the UV measurement head is configured to transmit the UV absorbance of a sample comprising unenriched milk to a program comprising a set of executable instructions configured to quantify the amount of protein and / or fat in the sample comprising unenriched milk. In some embodiments, the UV measurement head is configured to transmit the UV absorbance of a sample comprising unenriched milk to a program comprising a set of executable instructions configured to quantify the amount of protein and fat in the sample comprising unenriched milk. In some embodiments, the UV measurement head is configured to transmit the UV absorbance of a sample comprising enriched milk to a program comprising a set of executable instructions configured to quantify the amount of protein and / or fat in the sample comprising enriched milk. In some embodiments, the UV measurement head is configured to transmit the UV absorbance of a sample comprising enriched sample to a program comprising a set of executable instructions configured to quantify the amount of protein and fat in the sample comprising enriched milk.

[0209] In some embodiments, the program is associated with an operating system having a user interface. In some embodiments, the method further comprises converting the UV absorbance of the sample comprising unenriched milk or the sample comprising enriched milk into a UV absorbance spectrum. In some embodiments, the method further comprises comparing the UV absorbance spectrum with a reference curve that is a UV absorbance spectrum of water or air (e.g., by subtracting the reference curve from the sample curve). In some embodiments, the method further comprises comparing the UV absorbance spectrum with a reference curve that is a UV absorbance spectrum of water. In some embodiments, the method further comprises comparing the UV absorbance spectrum with a reference curve that is a UV absorbance spectrum of air. The determination of protein and / or fat content in the sample may be determined based on a comparison of the reference and the measurement of the sample. The protein and fat concentration may be determined by using a PLS regression, which may be applied to the absorbance. In some embodiments, the reference may be redone if its older than about 2 minutes, about 3 minutes, or about 5 minutes. In some embodiments, the reference may be redone if its older than 2 minutes, 3 minutes, or 5 minutes. In some embodiments, the reference may be redone before each breast milk sample measurement. In some embodiments, a first measurement may be discarded to allow for thermal effect to stabilize and for corresponding reference data to be obtained once thermal effects have stabilized.

[0210] In some embodiments, the system may analyze data from one or more samples (e.g., of breast milk) and from one or more corresponding reference samples. UV absorbance data from all samples and references to be analyzed may be loaded. The data may be processed using the wavelength region of 280 nm to 320 nm. In some embodiments, each sample may be compared to its corresponding reference, and absorbance for each sample may be calculated.

[0211] In some embodiments, data processing may include applying one or more preprocessing steps, such as a digital filter for smoothing. In some embodiments, for protein content determination, absorbance data may be preprocessed using a Savitzky-Golay Filter using a window of lOpx, polynomial order of 2, and the first derivative. In some embodiments, for protein content determination, absorbance data may be preprocessed using a Savitzky-Golay Filter using a window of lOpx, polynomial order of 2, and no derivative. For protein, there is a very prominent peak at the region around 280 nm, due to aromatic ring signals attributed to Trp,Tyr, and Phe amino residues. For fat, there is not a prominent signal in the UV region. Thus, to analyze fat content, the novel techniques disclosed herein are required.

[0212] In some embodiments, because all data is loaded, the PLS may be trained with different components to determine its best performance. This may be done in a loop and may be evaluated with cross-value prediction. The metrics for the prediction performance may be the RMSE and R2 values, which may be used to determine similarity between sample data and reference data. R2 may be indicative of similarity between two comparands, whereas RMSE may be indicative of difference between comparands. The PLS may be trained again with the optimized number of components and may then, in some embodiments, be ready for deployment.

[0213] FIG. 8A shows an example of a region of UV spectra for 10 samples between 270 nm and 240 nm. As shown by the vertical lines, fat content is assessed based on UV absorbance readings at 335 nm, and protein content is assessed based on the difference in UV absorbance readings for a sample at 335 nm and at 283 nm. In some embodiments, the absorbance reading for fat content may be made across a range of 300 + / - 50 nm. The ten sample spectra shown are for samples having different protein and fat concentrations. The spectra are shown in brackets in g / lOOml, with the first number in brackets indicating the concentration for protein and the second number in brackets indicating the concentration for fat.

[0214] FIG. 8B shows absorbance measurements obtained from the spectra shown in FIG. 8A, after applying a Savitzky-Golay Filter. The filtered spectra for ten different samples have different protein and fat concentrations, with concentrations shown in brackets in g / lOOml, with the first number in brackets indicating the concentration for protein and the second number in brackets indicating the concentration fat.

[0215] FIG. 8C shows accuracy of the measurement of protein (1 (left)) and fat (2 (right)) concentrations (in g / 100 ml) as measured by the UV-spectroscopy with the disclosed UV measurement head (Y axis) versus the same samples, measured by MIR-middle infrared spectroscopy (using commercial device acquired from Miris AB) (X axis). In some embodiments, in higher concentrations, the data is sparse and thus the algorithm may be less precise. In some embodiments, fat prediction may be more inaccurate than protein prediction using the techniques disclosed herein.

[0216] In some embodiments, the UV measurement head comprise electronics as shown in FIG. 7. As shown in FIG. 7, the electronics for the UV measurement head may include a battery management system coupled to a battery and to a USB interface. The battery management system may further be coupled to a step-up converter, which may in turn be coupled to a timer and to an LED driver. The timer may receive a start signal and control the LED driver.

[0217] In some embodiments, the electronics may allow the UV measurement head to function as a standalone measurement head without requiring an external power supply. The electronics may allow the UV measurement head to be controlled via software associated with the spectrometer, with integrated safety features to prevent UV illumination when the UV measurement head is in the open position. The LED may have a forward voltage of around 7 volts at a current of 50 mA.

[0218] The battery may be a Li-Ion battery (e.g., 1.45 Ah, Jauch Quartz). The battery may contain a safety circuit, and may thus be additionally protected from any failures of charging, discharging, and short circuits. Current drawn from the battery may flow from the anode through the circuit back through a power switch to a cathode. In a failure event, the power switch would disconnect the ground connection from the battery to the circuit.

[0219] In some embodiments, the UV measurement head may be used while charging with the power selection IC TPS2116 (Texas Instruments). In some embodiments in this mode, the higher voltage is always the power supply. While charging, the device may be powered through the USB-Port. Further, the device may be enabled through switch XI, which may enable the MosFet VI.

[0220] The boost converter TPS6161 (Texas Instrument) is used as a constant current source. It boosts up the power supply voltage to the forward voltage of the working point of the LED. The current is set through the resistor R11. The converter is enabled through a high signal on the pin CTRL. The set current of 44 mA for the UV-Led may be too high and saturates the spectrometer. The resistance R11 may be set to 53 Ohm. This allows to measure the airgap with the lowest possible integration time.

[0221] The enable pulse for the boost converter may be given by the timer TLC555 (Texas Instruments). It can be adjusted by the potentiometer R9 in the range of 1.22 s to 3.77 s. This feature, in some embodiments, is not used since the spectrometer controls the on- and off-time of the LED.

[0222] In some embodiments, to ensure the device is closed and ready to operate, the device may need a low signal on the trigger input. This can be achieved by closing the reed switch X5 with a magnetic field and an IR pulse to the phototransistor V7. The corresponding magnet and IR Led may be incorporated into the housing.

[0223] In some embodiments, the process of preparing and / or using the UV measurement head may be a simplified as compared to preparation and use of MIR-based measurement devices. To use the UV measurement head, a HMOF sample may be diluted 1 :9 (while for nonconcentrated milk, there may be no need to dilute). There may be no need for any preheating or sonication. The sample may then be vortexed for 30 seconds prior to UV measurement.Referencing by water or by air may then be performed. Comparatively, MIR-based systems may require sonication and prehearing, and may require referencing by a special buffer composition (e.g., a pH-stable buffer solution). Furthermore, MIR-based systems may require that, each time after 10 samples have been measured, the system is cleaned with a cleaner (which is not required in the UV-based systems disclosed herein). Furthermore, MIR-based systems may require two calibration solutions with known concentration of fat, protein, and carbohydrates, prepared from cow milk, to be used for calibration. In general, preparation of MIR-based systems can take from 30 to 60 minutes or more, while the UV-based systems disclosed herein may use only water or air as referencing and may be prepared for measurement in about one minute.

[0224] In some embodiments, alignment of components of the UV measurement head along a common optical axis may allow for the UV measurement head to function without the need for optical fibers. For example, the LED light source, cuvette with the sample liquid, focusing lens, and entrance slit of the spectrometer may all be aligned along a common optical axis with one another. This design may obviate the need for optical fibers for light transport, and is therefore very efficient.

[0225] In some embodiments, the UV measurement head may comprise a thermoregulator inside the sample cuvette.III. ENRICHMENT DEVICE

[0226] In some aspects, provided is a device for recovery of a protein- and fat-enriched fraction of human or animal breast milk. In some embodiments, the device allows for recovery of a protein- and fat-enriched fraction of human or animal breast milk outside of a laboratory setting. In some embodiments, use of the device does not require any professional laboratory knowledge. In some embodiments, the device may be used by laypeople. In some embodiments, the device may be used by nurses.

[0227] In some aspects, provided is a device that is an enrichment device configured to obtain a protein and fat enriched fraction from unenriched breast milk, wherein the device comprises: a filtration unit comprising an ultrafilter and a reservoir, wherein the filtration unit is configured to separate a protein and fat enriched retentate from a protein and fat reduced filtrate.

[0228] In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to about 100 kDa. In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to about 50 kDa. In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to about 30 kDa.

[0229] In some embodiments, the enrichment device further comprises a second reservoir configured to receive the protein and fat reduced filtrate from the filtration unit. In some embodiments, the enrichment device further comprises a weight sensor, wherein: the weight sensor is associated with the filtration unit and is configured to provide a real-time weight reading of the protein and fat enriched retentate; or the weight sensor is associated with the second reservoir and is configured to provide a real-time weight reading of the protein and fat reduced filtrate. In some embodiments, the weight sensor is associated with the filtration unit and is configured to provide a real-time weight reading of the protein and fat enriched retentate. In some embodiments, the weight sensor is associated with the second reservoir and is configured to provide a real-time weight reading of the protein and fat reduced filtrate.

[0230] In some embodiments, the enrichment device further comprises one or more pressure valves connected with the filtration unit. In some embodiments, the enrichment device further comprises one or more pressure valves connected with the filtration unit, wherein one or more pressure valves are configured to provide a positive air pressure to the filtration unit. In some embodiments, the enrichment device further comprises one pressure valve connected with the filtration unit, wherein the pressure valve is configured to provide a positive air pressure to the filtration unit. In some embodiments, the enrichment device further comprises two pressure valves connected with the filtration unit, wherein one pressure valve is configured to provide a positive air pressure to the filtration unit. In some embodiments, the enrichment device further comprises one or more pressure sensors integrated with each of the one or more pressure valves. In some embodiments, the enrichment device further comprises one or more pressure sensors integrated with each of the one or more pressure valves, wherein the pressure sensors are configured to monitor the air pressure inside the filtration unit. In some embodiments, one or more pressure valves are configured to release air and decrease an air pressure inside the filtration unit. In some embodiments, a first pressure valve is configured to provide a positive air pressure to the filtration unit, and a second pressure valve is configured to release air and decrease the air pressure inside the filtration unit.

[0231] In some embodiments, the enrichment device is configured to transmit one or more parameters to a program comprising a set of executable instructions for controlling one or more controllable parameters of the enrichment device. In some embodiments, the one or more parameters the enrichment device is configured to transmit are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of the protein and fat reduced filtrate. In some embodiments, the enrichment device is configured to transmit an air pressure inside the filtration unit. In some embodiments, the enrichment device is configured to transmit a stirring speed inside the filtration unit. In some embodiments, the enrichment device is configured to transmit a temperature around the filtration unit. In some embodiments, the enrichment device is configured to transmit an amount of time that has passed. In some embodiments, the enrichment device is configured to transmit a weight reading of the protein and fat enriched retentate. In some embodiments, the enrichment device is configured to transmit a weight reading of theprotein and fat reduced filtrate. In some embodiments, the enrichment device is configured to transmit an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit. In some embodiments, the enrichment device is configured to transmit an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, and a weight reading of the protein and fat enriched retentate. In some embodiments, the enrichment device is configured to transmit an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, and a weight reading of the protein and fat reduced filtrate.

[0232] In some embodiments, the one or more controllable parameters of the enrichment device are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit. In some embodiments, a controllable parameter of the enrichment device is an air pressure inside the filtration unit. In some embodiments, a controllable parameter of the enrichment device is a stirring speed inside the filtration unit. In some embodiments, a controllable parameter of the enrichment device is a temperature around the filtration unit. In some embodiments, the controllable parameter of the enrichment device is an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit.

[0233] In some embodiments, the program comprising a set of executable instructions is configured to change an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and / or a temperature around the filtration unit upon the enrichment device transmitting a particular weight reading of the protein and fat enriched retentate or a particular weight reading of the protein and fat reduced filtrate. In some embodiments, the program comprising a set of executable instructions is configured to change an air pressure inside the filtration unit and a stirring speed inside the filtration unit. In some embodiments, the program comprising a set of executable instructions is configured to change an air pressure inside the filtration unit and a stirring speed inside the filtration unit upon the enrichment device transmitting a particular weight reading of the protein and fat enriched retentate. In some embodiments, the program comprising a set of executable instructions is configured to change an air pressure inside the filtration unit and a stirring speed inside the filtration unit upon the enrichment device transmitting a particular weight reading of the protein and fat reduced filtrate. In someembodiments, the particular weight reading of the protein and fat enriched retentate is about one third of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat reduced filtrate is about two thirds of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat enriched retentate is about one half of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat reduced filtrate is about one half of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat enriched retentate is about one seventh of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat reduced filtrate is about six sevenths of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat enriched retentate is about one ninth of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat reduced filtrate is about eight ninths of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat enriched retentate is about one tenth of the original weight of the unenriched milk. In some embodiments, the particular weight reading of the protein and fat reduced filtrate is about nine tenths of the original weight of the unenriched milk.

[0234] In some embodiments, the program is associated with an operating system having a user interface. In some embodiments, the program is associated with an operating system external to the enrichment unit. In some embodiments, the program is associated with an operating system incorporated into the enrichment unit. In some embodiments, the program is associated with an operating system incorporated into the enrichment unit, and the user interface is incorporated into the enrichment unit.

[0235] In some embodiments, the device allows for a substantial reduction in the final cost of human milk origin fortifiers (HMOFs) compared with current industrial products. In some embodiments, the device allows for HMOFs to be more available in developed countries and developing countries. In some embodiments, the device allows for better outcomes for preterm infants. In some embodiments, administration of the HMOFs produced using the device described herein reduces the total duration of hospitalization of an infant. In some embodiments, administration of the HMOFs produced using the device described herein reduces hospitalspending. In some embodiments, administration of the HMOFs produced using the device described herein reduces the cost of donor milk. In some embodiments, administration of the HMOFs produced using the device described herein decreases the price of HMOFs. In some embodiments, use of the device reduces the environmental impact of the production of HMOFs. In some embodiments, use of the device reduces the amount of HMOFs that are shipped. In some embodiments, use of the device enables HMOFs to be prepared locally.

[0236] In some variations, the fat- and protein-enriched retentate obtained from the device is suitable for administration to a premature or full-term newborn infant. In some embodiments, the retentate is suitable for administration to a premature or full-term newborn infant after dilution with a suitable amount of human breast milk. In some embodiments, the dilution with a suitable amount of human breast milk is tailored to the infant’s daily required amount of protein and / or fat. In some aspects, the enrichment device may also be used in the rearing of animals. In some embodiments, the enrichment device may be used in the framework of zoological breeding programs.

[0237] In some aspects, the exemplary enrichment device and method provided herein substantially reduce the risk of losing fat and proteins compared to the currently-used protocols that have multiple steps.

[0238] In some embodiments, the one-step filtration of human breast milk to provide a HMOF composition is controlled and stopped automatically, for example in response to an automatic target weight for a retentate and / or filtrate being reached. Volume may be determined automatically based on measured weight, which may be converted by the system to a volume. In some embodiments, the one-step filtration of human breast milk to provide a HMOF composition is controlled automatically. In some embodiments, the one-step filtration of human breast milk to provide a HMOF composition is stopped automatically.

[0239] In some embodiments, the enrichment device comprises a filtration unit. In some embodiments, the filtration unit comprises a reservoir. In some embodiments, the reservoir hosts an ultra-filter. In some embodiments, the ultra-filter is single-use. In some embodiments, the ultra-filter is replaceable. In some embodiments, the enrichment device comprises a waste collector. In some embodiments, the waste collector is configured to receive a fat- and protein-reduced filtrate. In some embodiments, the waste collector is connected to the enrichment device through a waste tube connector.

[0240] In some embodiments, a set of silicone O-rings hosts the filter. In some embodiments, a set of silicone O-rings closes the filter floor and cover. In some embodiments, one or more sets of silicone O-rings is autoclavable. In some embodiments, one or more sets of silicone O-rings is single-use. In some embodiments, one or more sets of silicone O-rings allow for efficient and hermetic closure. In some embodiments, one, two, or more clamps fix the filter floor and cover with the filtration unit. In some embodiments, a magnet bar is placed in the filtration unit. In some embodiments, the magnet bar is autoclavable. In some embodiments, the filtration unit is placed in a cooling chamber. In some embodiments, the filtration unit is attached to a source of air pressure. In some embodiments, the filtration unit is attached to a tube that connects the filtration unit to a second reservoir (e.g., a waste reservoir) (see FIG. 3 and FIG. 4). As shown in FIG. 3, components of a filtration unit may include a container (1), a cover (2), a connector and o-ring (or a plurality of sets thereof) (3), one or more seals (4), a clamp cover (5), a bottom plate (6), a filter (7) a magnet (8), a waste tube (9), and a clamp bottom (10). (Note that components in FIG. 4 are labeled differently.)

[0241] In some embodiments, the filtration unit has a locker, allowing to close and open the bottom part relative to the rest of the filtration unit by a single movement (FIG. 4A).

[0242] In some embodiments, the filtration unit has no connection tube with waste container but a direct hole connecting the filtration unit with the waste container (FIG. 2G). The waste containing tube is located inside the central hole of the supporting plate and can be removed after each usage for proper cleaning. The bottom plate has a central hole, which can be closed by a removable tap before or after usage (FIG. 2G, A).

[0243] In some embodiments, the filtration unit has a connection with the air filter (FIG. 4B) The connection is located on the lid of the filtration unit and the filter has a connection directly with the lid without any connection tube between the filter and the lid. The air filter is a single-use item and exchangeable after each use to meet hygiene standards.

[0244] In some embodiments, air pressure is monitored during enrichment. In some embodiments, the temperature around the retentate is monitored during enrichment. In some embodiments, the temperature around the second reservoir is monitored during enrichment. In some embodiments, the weight of the retentate is measured during enrichment. In some embodiments, the weight of the liquid in the second reservoir is measured during enrichment. In some embodiments, magnetic stirring speed is monitored during enrichment. In some embodiments, the liquid level inside the filtration unit is monitored during enrichment. In some embodiments, the liquid level inside the filtration unit is monitored during enrichment based on a weight measurement. In some embodiments, the total time that has passed is monitored during enrichment.

[0245] In some embodiments, the fat- and protein-enriched retentate is kept under constant stirring. In some embodiments, the fat- and protein-enriched retentate is kept under constant cooling. In some embodiments, the fat- and protein-enriched retentate is kept under constant stirring and cooling. In some embodiments, the stirring regime is changed based on the level of the retentate. In some embodiments, the stirring regime is changed automatically. In some embodiments, the air pressure is changed based on the level of the retentate. In some embodiments, the air pressure is changed automatically. In some embodiments, the stirring regime and / or air pressure is changed to a lower value as the enrichment process occurs. In some embodiments, the stirring regime and / or air pressure is changed to a lower value when the volume of the retentate is about one third the volume of the original milk sample. In some embodiments, changing the stirring regime and / or air pressure is a safety measure. In some embodiments, changing the stirring regime and / or air pressure prevents or mitigates the formation of foam. In some embodiments, changing the stirring regime and / or air pressure reduces the formation of foam.

[0246] In some embodiments, it is desirable to prevent or mitigate the formation of foam. In some embodiments, foam formation in the retentate or enriched milk results in increased difficulty for a human operator to collect the enriched milk from the enrichment device. In some embodiments, foam formation in the retentate or enriched milk results in a decreased yield. In some embodiments, foam formation in the retentate or enriched milk results in the enriched milk not being suitable for feeding to an infant.

[0247] In some embodiments, the filtration unit is connected to a pressure valve. In some embodiments, the pressure valve is configured to provide positive air pressure to the filtration unit. In some embodiments, the filtration unit is connected to a second pressure valve. In some embodiments, the second pressure valve allows for the slow release of the pressured air at the end of the enrichment process. In some embodiments, the second pressure valve prevents or mitigates the formation of foam. In some embodiments, the second pressure valve reduces the formation of foam. In some embodiments, the second pressure valve allows the enrichment device to be safely opened by the operator. In some embodiments, a magnetic stirrer and / or one or more pressure valves are connected to an operating system. In some embodiments, the operating system is connected to the enrichment device through USB. In some embodiments, the second reservoir is a waste collector or waste container. In some embodiments, the waste collector is connected to a weight detector. In some embodiments, the weight detector is connected to an operating system. In some embodiments, the operating system is connected to the weight detector through USB. In some embodiments, the operating system connected to the magnetic stirrer allows for an autonomous enrichment process. In some embodiments, the operating system connected to the magnetic stirrer allows for an autonomous enrichment process with changeable stirring regimes based on the weight of the retentate. In some embodiments, the operating system connected to the one or more pressure valves allows for an autonomous enrichment process. In some embodiments, the operating system connected to the one or more pressure valves allows for an autonomous enrichment process, with changeable air pressures based on the weight of the retentate. In some embodiments, the operating system connected to the weight detector allows for an autonomous enrichment process. In some embodiments, the operating system connected to the one or more air pressure valves allows for the enrichment device to be stopped when the enrichment process is complete. In some embodiments, the operating system connected to the stirring device allows for the enrichment device to be stopped when the enrichment process is complete. In some embodiments, the operating system connected to the weight detector allows for the enrichment device to be stopped when the enrichment process is complete. In some embodiments, the enrichment process is complete once the retentate volume has been reduced to a desired level. In some embodiments, the enrichment process is complete once the weight of the retentate has been reduced to a desired weight. In some embodiments, the enrichment process is complete once the volume of liquid in the secondreservoir reaches a desired level. In some embodiments, the enrichment process is complete once the weight of the liquid in the second reservoir reaches a desired weight. In some embodiments, the air valves are equipped with pressure sensors. In some embodiments, the pressure sensors allow for the filtration pressure to be monitored. In some embodiments, the pressure sensors allow for the filtration pressure to be changed based on the weight of the retentate.

[0248] In some aspects, provided is a device for obtaining a protein- and fat-enriched fraction from human or animal milk. In some embodiments, the device is used on-site. In some embodiments, the device simplifies the process of obtaining a protein- and fat-enriched fraction from milk as compared to current industrial protocols. In some aspects, provided is a device for protein and fat enrichment of human breast milk. In some embodiments, the device comprises a protein and fat enrichment unit. In some embodiments, the enrichment device comprises a filtration unit, a first reservoir, an ultrafilter, a system of pressure valves, a second reservoir, a magnetic stirrer under the filtration unit, and a weight-sensor. In some embodiments, the enrichment device comprises a filtration unit, a first reservoir, an ultrafilter, a system of pressure valves, a second reservoir, a magnetic stirrer under the filtration unit, and a weight-sensor. In some embodiments, the enrichment device comprises sensors for the door locker and the waste container. In some embodiments, the waste container has temperature-regulated sensors.

[0249] In some embodiments, the ultrafilter is configured to provide a fat- and protein- enriched retentate from breast milk. In some embodiments, the ultrafilter is configured to provide a human milk origin fortifier (HMOF) from human breast milk. In some embodiments, the ultrafilter is configured to provide a fat- and protein-reduced filtrate. In some embodiments, the fat- and protein-reduced filtrate is a waste fraction. In some embodiments, a first pressure valve is in connection with the first reservoir and the ultrafilter. In some embodiments, a first pressure valve is configured to provide positive air pressure to the filtration unit. In some embodiments, a second pressure valve is configured to release the positive air pressure from the filtration unit. In some embodiments, the second pressure valve releases the positive air pressure from the filtration unit when the enrichment process is finished. In some embodiments, the air pressure is released before the filtration unit is opened. In some embodiments, a tube connects the filtration unit and the second reservoir. In some embodiments, a tube is configured to deliver a fat- and protein-reduced filtrate from the ultrafilter to the second reservoir. In some embodiments, thereis no tube connecting the filtration unit and the second reservoir. In some embodiments, a central hole is located in the bottom of the filtration unit, which is centralized versus the hole on the supporting plate of the filtration unit. The waste-containing tube is inserted into the hole to the waste container to collect the waste (filtrate) to the waste-reservoir.

[0250] In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to about 100 kDa. In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to 100 kDa. In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to about 50 kDa. In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to 50 kDa. In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to about 30 kDa. In some embodiments, the ultrafilter has a nominal molecular weight limit of less than or equal to 30 kDa.

[0251] In some embodiments, the filtration is conducted under a stirring regime. In some embodiments, the filtration is conducted under a constant stirring regime. In some embodiments, the stirring regime prevents fats and proteins from non-specifically precipitating to the ultrafilter. In some embodiments, the stirring regime reduces the number of fats and proteins blocking the ultrafilter. In some embodiments, the stirring regime ranges from 150 to 200 rpm. In some embodiments, the stirring regime ranges from 75 to 100 rpm. In some embodiments, the stirring regime is kept constant throughout the enrichment process. In some embodiments, the stirring speed is reduced during the enrichment process. In some embodiments, the stirring regime ranges from 150 to 200 rpm during the first 10%, 20%, 30%, 40%, 50%, 60%, 70%, or 80% of the enrichment process, wherein the percent of the enrichment process that has been completed is determined by the percent volume reduction of the retentate. In some embodiments, the stirring regime ranges from 150 to 200 rpm when the volume of the retentate is 100% to 33% of its initial volume. In some embodiments, the stirring regime ranges from 150 to 200 rpm during the first 10%, 20%, 30%, 40%, 50%, 60%, 70%, or 80% of the enrichment process, wherein the percent of the enrichment process that has been completed is determined by the amount of time that has passed compared to the total amount of time of the enrichment process. In some embodiments, the stirring regime ranges from 75 to 100 rpm during the final 10%, 20%, 30%, 40%, 50%, 60%, 70%, or 80% of the enrichment process, wherein the percent of the enrichmentprocess that has been completed is determined by the percent volume reduction of the retentate. In some embodiments, the stirring regime ranges from 75 to 100 rpm when the volume of the retentate is less than 33% of its original volume. In some embodiments, the stirring regime ranges from 150 to 200 rpm during the first 10%, 20%, 30%, 40%, 50%, 60%, 70%, or 80% of the enrichment process, wherein the percent of the enrichment process that has been completed is determined by the amount of time that has passed compared to the total amount of time of the enrichment process. In some embodiments, reducing the stirring speed during the enrichment process prevents or mitigates the formation of foam. In some embodiments, reducing the stirring speed during the enrichment process reduces the formation of foam. In some embodiments, the magnetic stirring is stopped when the enrichment process is complete. In some embodiments, a magnet is placed inside the first reservoir before the enrichment process begins. In some embodiments, at lower than 50 rpm, the stirring speed may be too slow and may not effectively prevent fat blockage of the filter. In some embodiments, if stirring is above 200rpm, foaming can occur, which is irreversible and cannot be recovered for feeding. In some embodiments, during a first stage, a stirring speed of 150 rpm to 200 rpm can be used, because liquid level may still be high and the bottom of the reservoir may be covered such that less or no foam will be created. When the volume is reduced to about 100 ml of liquid is remaining, the risk of air contact area increases, because stirring happen so fast, that the bottom of the reservoir can be exposed as the liquid is agitated. This creates a much higher risk for foam formation, so a second stirring regime with less pressure and lower stirring speed may be automatically engaged. Gentler parameters with lower pressure and lower stirring speed may prevent or mitigate exposure of the bottom of the reservoir and discourage foam formation.

[0252] In some embodiments, a positive air pressure is a driving force for the ultrafiltration. In some embodiments, a positive one-way air pressure is used for dead-end filtration. In some embodiments, the values of the air pressure are monitored. In some embodiments, the values of the air pressure are automatically changed depending on the stage of enrichment. In some embodiments, values of the air pressure are automatically changed by an internal operating system. In some embodiments, the values of the air pressure are automatically changed by an external operating system. In some embodiments, the filtration is conducted at a constant pressure. In some embodiments, the air pressure is reduced during the enrichment process. In some embodiments, the air pressure ranges from 2 bar to 4 bar during the first 10%, 20%, 30%,40%, 50%, 60%, 70%, or 80% of the enrichment process, wherein the percent of the enrichment process that has been completed is determined by the percent volume reduction of the retentate. In some embodiments, the air pressure ranges from 2 bar to 4 bar when the volume of the retentate is 100% to 33% of its initial volume. In some embodiments, the air pressure ranges from 2 bar to 4 bar during the first 10%, 20%, 30%, 40%, 50%, 60%, 70%, or 80% of the enrichment process, wherein the percent of the enrichment process that has been completed is determined by the amount of time that has passed compared to the total amount of time of the enrichment process. In some embodiments, the air pressure ranges from 0.5 bar to 1 bar during the final 10%, 20%, 30%, 40%, 50%, 60%, 70%, or 80% of the enrichment process, wherein the percent of the enrichment process that has been completed is determined by the percent volume reduction of the retentate. In some embodiments, the air pressure ranges from 0.5 bar to 1 bar when the volume of the retentate is less than 33% of its original volume. In some embodiments, the air pressure ranges from 0.5 bar to 1 bar during the first 10%, 20%, 30%, 40%, 50%, 60%, 70%, or 80% of the enrichment process, wherein the percent of the enrichment process that has been completed is determined by the amount of time that has passed compared to the total amount of time of the enrichment process. In some embodiments, reducing the air pressure during the enrichment process prevents or mitigates the formation of foam. In some embodiments, reducing the air pressure during the enrichment process reduces the formation of foam. In some embodiments, the enrichment process is stopped by an internal operating system. In some embodiments, the enrichment process is stopped by an external operating system. In some embodiments, the air pressure is released when the enrichment process is complete. In some embodiments, the air pressure is released for an average of 0.5 to 5 minutes when the enrichment process is complete. In some embodiments, the air pressure is slowly decreased for an average of 0.5 to 5 minutes when the enrichment process is complete. In some embodiments, the air pressure is released for an average of 2 minutes when the enrichment process is complete. In some embodiments, the air pressure is slowly decreased for an average of 2 minutes when the enrichment process is complete.

[0253] In some embodiments, pressure in the range of 2 to 4 bars may be used when about 25% or more liquid is remaining in the reservoir, or when about 2 cm or more liquid is remaining in the reservoir. After less than 25% of liquid or about 2 cm or less liquid is remaining in thereservoir, a second pressure regime with less pressure (and, optionally lower stirring speeds) may be used, to discourage foam formation.

[0254] In one example, 500 ml of liquid is in the reservoir and the desire is to concentrate it about x7, to 70ml as a final volume. In this example, reducing to 100ml at a first regime can be safe, and after that point a second, gentler regime for pressure and / or stirring speed may be engaged. This converts to about 20-25% remaining at which point the second regime is engaged, with typical diameters for the reservoir as described herein. For each diameter, this percentage value may be different, to cover the reservoir bottom sufficiently and avoid foam formation. Thus, if a smaller diameter reservoir is used, the percentage numbers may be different (e.g., not 25%, but 10% as trigger). If the size of diameter is larger, then a larger trigger volume percentage to start the second regime (e.g., 40%) may be used. In general, it may be desirable to keep at least about 2 cm of milk or more above the bottom of the reservoir. In some embodiments, the enrichment process is conducted at a temperature colder than room temperature. In some embodiments, conducting the enrichment process at a cool temperature prevents or mitigates the growth of pathogens during the enrichment process. In some embodiments, conducting the enrichment process at a cool temperature reduces the growth of pathogens during the enrichment process. In some embodiments, the enrichment process is performed between 2 and 8 C. In some embodiments, the temperature is maintained during the enrichment process. In some embodiments, the temperature is monitored during the enrichment process. In some embodiments, the temperature is controlled during the enrichment process.

[0255] In some embodiments, the status of the enrichment process is monitored using a weight sensor. In some embodiments, the level of retentate inside the filtration unit is measured. In some embodiments, the level of retentate inside the filtration unit is measured by its weight. In some embodiments, the level of retentate inside the filtration unit is determined using the weight of the filtrate inside the second reservoir. In some embodiments, the weight sensor measures the weight of the liquid inside the filtration unit in real time. In some embodiments, the weight sensor measures the weight of the liquid inside the second reservoir in real time. In some embodiments, the data from the weight sensor are monitored by an internal operating system. In some embodiments, the data from the weight sensor are monitored by an external monitoringsystem. In some embodiments, the weight sensor is connected to an external monitoring system through a USB connection. In some embodiments, the operating system stops the enrichment process when the desired remaining level of retentate is reached.

[0256] In some embodiments, the status of the enrichment process is monitored using a system other than a weight sensor. In some embodiments, the status of the enrichment process is monitored using an optical sensor. In some embodiments, the status of the enrichment process is measured using infrared spectroscopy. In some embodiments, the status of the enrichment process is monitored using a UV measurement head as described herein. In some embodiments, the status of the enrichment process is measured using electrodes. In some embodiments, the status of the enrichment process is measured using sonication. In some embodiments, the status of the enrichment process is measured using ultrasound.

[0257] In some embodiments, it is desirable for the status of the enrichment process to be monitored using a system which does not involve contacting a measurement-taking device directly with the enriched milk or liquid in the second reservoir. In some embodiments, using a measurement-taking device that requires direct contact with the enriched milk or liquid in the second reservoir results in decreased hygiene as compared to a measurement-taking device that does not require direct contact with the enriched milk or liquid in the second reservoir. In some embodiments, a weight sensor below the filtration device is a measurement-taking device that does not require direct contact with the enriched milk or liquid in the second reservoir. In some embodiments, a weight sensor below the second reservoir is a measurement-taking device that does not require direct contact with the enriched milk or liquid in the second reservoir.

[0258] In some embodiments, the enrichment process occurs in less than 48 hours. In some embodiments, the enrichment process occurs in less than 24 hours. In some embodiments, the enrichment process occurs in a maximum of 48 hours. In some embodiments, limiting the enrichment process to 48 hours meets hygienic requirements. In some embodiments, limiting the enrichment process to 48 hours and maintaining an operating temperature of 2 to 8 C meets hygienic requirements.

[0259] In some embodiments, an operating system stops the enrichment process when a desired volume reduction is reached. Volume may be monitored automatically by the weightsensor(s) below the reservoir(s) as described herein. For example, a weight sensor may measure weight of the retentate in the reservoir, and the weight of the retentate may be automatically converted by the system to a volume of retentate. In some embodiments, a human operator stops the enrichment process when a desired volume reduction is reached. In some embodiments, the desired volume reduction is a volume of one fifth to one tenth of the initial volume of the unenriched milk. In some embodiments, the desired volume reduction is a volume of one quarter to one tenth of the initial volume of the unenriched milk. In some embodiments, the desired volume reduction is a volume of one quarter to one seventh of the initial volume of the unenriched milk. In some embodiments, the total concentration of fat and protein is increased proportionally with the total reduction of the retentate volume.

[0260] In some embodiments, the enriched milk has about 70% to about 90% of the total protein and fat as compared to the unenriched milk. In some embodiments, around 10% of the fat and protein is lost during the enrichment process. In some embodiments, fat and protein loss is caused by unspecific binding of fat and protein to the ultrafilter. In some embodiments, fat and protein loss is caused by unspecific binding of fat and protein to the walls of the filtration unit. In some embodiments, fat and protein loss is caused by unspecific binding of fat and protein to the filtration unit.

[0261] In some embodiments, the concentration of the fat and protein of the enriched milk is around 2 to around 10 times higher than the concentration of the fat and protein of the nonenriched milk. In some embodiments, the concentration of the fat and protein of the enriched milk is around 3 to around 9 times higher than the concentration of the fat and protein of the nonenriched milk. In some embodiments, the concentration of the fat and protein of the enriched milk is around 3 times higher than the concentration of the fat and protein of the nonenriched milk. In some embodiments, the concentration of the fat and protein of the enriched milk is around 9 times higher than the concentration of the fat and protein of the nonenriched milk.

[0262] In some embodiments, the desired retentate volume is around one fourth to around one tenth of the initial volume of the unenriched milk. In some embodiments, the desired retentate volume is dependent upon the initial fat content of the milk. In some embodiments, the enrichment process is stopped when the fat concentration of the retentate reaches around 20 g / 100 ml. In some embodiments, stopping the enrichment process at this fat concentration prevents or discourages the retentate from solidifying. In some embodiments, the maximum final fat concentration of the retentate is around 20 g / 100 ml. In some embodiments, the initial unenriched milk has a relatively high amount of fat. In some embodiments, a relatively high amount of fat is from about 2.0 to about 4.0 g / 100 ml. In some embodiments, the enrichment process concentrates unenriched milk with a relatively high amount of fat by a factor of about 5 to about 7. In some embodiments, a human operator may measure the initial fat content of the unenriched milk. In some embodiments, a human operator may measure the initial fat content of the unenriched milk and evaluate the maximum concentration factor. In some embodiments, the human operator is a nurse. In some embodiments, the human operator may measure the initial fat content of the unenriched milk using the UV-based sensor described herein.

[0263] In some embodiments, the enriched milk is pasteurized. In some embodiments, the enriched milk is stored before pasteurization. In some embodiments, the enriched milk is frozen before pasteurization.

[0264] In some embodiments, the final volume of the enriched milk is around 100 ml. In some embodiments, the enriched milk is aliquoted into 20 ml average daily portions before pasteurization.

[0265] In some embodiments, pasteurization is conducted at around 60 to around 65 °C. In some embodiments, pasteurization is conducted at about 63.5 °C. In some embodiments, pasteurization is conducted for about 30 minutes. In some embodiments, pasteurization is conducted at about 63.5 °C for about 30 minutes.

[0266] In some embodiments, the enriched milk is not administered to an individual before being diluted. In some embodiments, the enriched milk is diluted with unenriched milk. In some embodiments, the ratio of the enriched milk to the unenriched milk can be predicted using software. In some embodiments, the software is embedded into the enrichment device. In some embodiments, the software is on an external operating system. In some embodiments, the ratio of the enriched milk to the unenriched milk is calculated based on gestational age, current weight, and / or volume of milk consumed by the individual. In some embodiments, the unenriched milk used to dilute the enriched milk is from the individual’s mother. In some embodiments, theunenriched milk used to dilute the enriched milk is from a donor. In some embodiments, the prediction of the ratio of the enriched milk to the unenriched milk allows for personalized nutrition. In some embodiments, he prediction of the ratio of the enriched milk to the unenriched milk reduces the danger of under- or over-fortification of the unenriched milk. In some embodiments, the prediction of the ratio of the enriched milk to the unenriched milk avoids the danger of under- or over-fortification of the unenriched milk. In some embodiments, a danger associated with over-fortification is an infant not digesting food properly. In some embodiments, dangers associated with under-fortification include lack of proper growth, lack of weight gain, complex health issues, improper brain development, and / or death.

[0267] In some embodiments, the device may be readily disassembled or assembled.

[0268] With reference to FIG. 4, an exemplary filtration unit is shown. At the top, a tube is fed into a push-in fitting 4, which is inserted through a cover 3 and feeds into a reservoir 1. A second input line is shown at the mini-hose tail 4. Either of the tube inputs can be configured as a pressure valve, for example, to provide positive air pressure to the filtration unit. The second tube unit can be configured as a pressure release valve to release air pressure from the filtration unit. The cover 3, which may be transparent or have a transparent window, is fitted against the reservoir with a clamp 7 and a seal 2 to hold the cover in place. At the bottom of the filtration unit, a filter floor 6 is secured to the reservoir 1 by a clamp 7 and a seal 2. The filter membrane 5 is held in place at the bottom of the filtration unit and in fluid connection with the reservoir 1 by the claim 7 and the seal 2. A mini-hose tail (not depicted) provides an output for protein- and fat- reduced filtrate.

[0269] With reference to FIG. 4A, an exemplary filtration unit is shown with a locker and the central hole in the bottom part. The locker can secure the closeness of the filtration unit. Once the enrichment is finished, the milk is poured outside and the filtration unit can be dissembled, if the locker is open.

[0270] With reference to FIG. 4B, an exemplary filtration unit is shown with two o-rings for bottom and lid and with the air filter attached directly to the lid.

[0271] In some embodiments, the various components of the device may be assembled and held together by means suitable to provide air- and liquid-tight sealing. In some embodiments, the device may comprise various screw fittings and / or clamp fittings to achieve fluid seal.

[0272] As detailed above, the device as provided by the present disclosure is designed for use at point of care, whether in a hospital for use by care providers for a given patient or at home for use by a breast feeding or pumping parent. In contrast to large-scale commercial manufacturing and processing sites, the device provided herein is configured in size and operational requirements for benchtop use, for example, in a hospital clinical or laboratory setting, or a tabletop or countertop use in a house.

[0273] In some embodiments, the device may be characterized by its dimensions, or physical footprint. In some embodiments, the device has a physical footprint of less than or equal to about 4 cubic meters. In some embodiments, the device has a physical footprint of less than or equal to about 3 cubic meters. In some embodiments, the device has a physical footprint of less than or equal to about 2 cubic meters. In some embodiments, the device has a physical footprint of less than or equal to about 1.5 cubic meters. In some embodiments, the device has a physical footprint of less than or equal to about 1 cubic meter.

[0274] In other embodiments, the device may be characterized by the maximum volumetric capacity of source human breast milk that the device is capable of processing. In some embodiments, the device has a capacity of less than or equal to about 5 L, less than or equal to about 2.5 L, less than or equal to about 2 L, or less than or equal to about 1.5 L. In other embodiments, the device has a capacity of greater than or equal to about 100 mL, greater than or equal to about 200 mL, greater than or equal to about 300 mL, greater than or equal to about 500 mL, greater than or equal to about 1 L, greater than or equal to about 1.5 L. In some embodiments, the device has a capacity of less than or equal to about 2 L. In some embodiments, the device has a capacity of between about 100 mL and about 5 L, between about 100 mL and about 5 L, between about 100 mL and about 5 L, between about 100 mL and about 5 L, between about 100 mL and about 2.5 L, between about 500 mL and about 5 L, between about 500 mL and about 2 L or between about 500 mL and about 1.5 L. In some embodiments, the device has acapacity of between about 500 mL and about 1.5 L. In other embodiments, the device has a capacity of between about 500 mL and about 2 L.

[0275] As detailed herein, the device allows for fat and protein enrichment of human breast milk on-site in a hospital or a residential setting. In some embodiments, the device directly produces food safe human milk origin fortifier compositions without further purification. In some embodiments, the enriched milk is pasteurized before being combined with unenriched milk. In some embodiments, pasteurizing the enriched milk kills bacteria. In some embodiments, pasteurizing the enriched milk is a hygienic measure. In some embodiments, the enriched milk is not pasteurized before being combined with unenriched milk. In some embodiments, the device is made of medical-grade or food-grade materials.

[0276] In some embodiments, the device is capable of processing at least about 2000 L of breast milk per device lifetime. In other embodiments, the device is capable of operating for at least about 1000 enrichment runs, optionally wherein the device processes between about 100 mL and about 2 L of unenriched human breast milk per enrichment run. In other embodiments, the device is capable of operating for at least about 1000 enrichment runs, optionally wherein the device processes between about 100 mL and about 1 L of unenriched human breast milk per enrichment run. In other embodiments, the device is capable of operating for at least about 1000 enrichment runs, optionally wherein the device processes between about 100 mL and about 0.5 L of unenriched human breast milk per enrichment run.

[0277] In some embodiments, the device may be disassembled. In some embodiments, the device may be sterilized. In some embodiments, the device may be autoclaved. In some embodiments, the device is resistant to high temperatures, such as the temperatures experienced in an autoclave. In some embodiments, device is resistant to high temperatures, optionally wherein the high temperatures are less than or equal to about 70 degrees Celsius, optionally wherein the high temperatures are between about 50 and about 60 degrees Celsius. In some embodiments, device is resistant to high temperatures, optionally wherein the high temperatures are less than or equal to about 135 degrees Celsius, optionally wherein the high temperatures are between about 120 and about 135 degrees Celsius.

[0278] In some embodiments, the enrichment device comprises glass and / or plastic. In some embodiments, the enrichment device comprises steel. In some embodiments, the enrichment device comprises steel and a transparent window comprising glass or plastic.

[0279] In some variations, the filter may be characterized by its material composition. In some variations, suitable materials for the filter may include but are not limited to cellulose or derivatives thereof (e.g., nitrocellulose), or polymers (e.g., polycarbonate, poly vinylidene fluoride). In some variations, the filter comprises glass fiber. In certain variations, the filter comprises polyvinylene difluoride, polycarbonate, mixed cellulose esters, or cellulose acetate. In some variations, the filter comprises glass microfiber, nitrocellulose, cellulose, or polyethersulfone. In some variations, the filter comprises poly ethersulfone. In some variations of the foregoing, the material of the first filter is food grade, e.g., as determined by the Food and Drug Administration.

[0280] In some embodiments, the enrichment device is configured to hold a filter having specific physical dimensions, such as diameter and / or thickness. In some embodiments, the enrichment device is configured to hold a first filter having a diameter between about 140 mm and about 160 mm, between about 140 mm and about 150 mm, between about 145 mm and about 150 mm, between about 147 mm and about 150 mm, or between about 147 mm and about 148 mm. In some embodiments, the enrichment device is configured to hold a filter having a diameter between about 70 mm and about 140 mm, between about 75 mm and about 140 mm, between about 76 mm and about 140 mm, or between about 90 mm and about 110 mm. In other embodiments, the enrichment device is configured to hold a filter having a thickness of between about 0.25 mm and about 1 mm, between about 1 mm and about 5 mm, between about 2 mm and about 10 mm, between about 2 mm and about 7 mm, between about 2 mm and about 5 mm, between about 5 mm and about 10 mm, between about 5 mm and about 7 mm, or between about 7 mm and about 10 mm. Below the ranges described herein, the filter may be blocked easily by fat. Above the ranges described herein, a risk can be created for foam formation due to too much contact with air. In some embodiments, for 0.5 L to 1.0 L, a maximum of 86mm filter may be used.

[0281] In some variations, it may be desirable for the air pressure of the enrichment device to be adjusted, either for positive or negative pressure, to expedite filtration. In some variations, it may be desirable for the positive air pressure of the enrichment device to be adjusted, to expedite filtration. In some embodiments, the enrichment device comprises a first pressure valve. In some embodiments, the first pressure valve is in fluid connection with the filter. In some embodiments, the first pressure valve is configured to provide positive air pressure to the enrichment device. In some embodiments, the first pressure valve is configured to provide positive air pressure generated by compressed air. In some embodiments, a second pressure valve is configured to release the positive air pressure at the end of the enrichment process.

[0282] In some embodiments, the first pressure valve is configured to supply between about 0.25 and about 4 bar of absolute pressure to the filtration unit. In some embodiments, the first pressure valve is configured to supply between about 1 and about 4 bar of absolute pressure to the filtration unit and filter. In some embodiments, the first pressure valve is configured to supply between about 2 and about 4 bar of absolute pressure to the filtration unit and filter. In some embodiments, the first pressure valve is configured to supply between about 3 and about 4 bar of absolute pressure to the filtration unit and filter. In some embodiments, the first pressure valve is configured to supply less than or equal to about 4 bar of absolute pressure to the filtration unit and filter. In some embodiments, the first pressure valve is configured to provide pressure from a compressed air canister. It should be recognized that the device as described herein may include additional components suitable to enable pressurization or de-pressurization of the filtration unit, including but not limited to sealing (O) rings, gaskets, clamps, quick release clamps, valves, tubing / hose(s), Swagelok connections, ferrules, etc. For additional security to open and close the unit is the locker system for the better connection of the bottom part with the filtration unit is introduced (FIG. 4A, 1, 2 and 4). The locker can be opened and closed by a single movement to make it more user-friendly and without the need of applying muscle force. In some embodiments, pressure that is above the ranges described herein (e.g., above 4 bars) may lead to protein aggregates formation and foam formation. In some embodiments, pressure that is below the ranges described herein may cause processing to be too slow and to exceed the allowed maximum time (e.g., 48 hours) allowed for processing by human milk storage regulations.

[0283] In addition, in some embodiments, the first pressure valve may further comprise an air filter, for example, to avoid contamination of the source human breast milk or the fat- and protein-enriched retentate.

[0284] In some embodiments, the enrichment device may be characterized by its maximum pressure tolerance. In some embodiments, the enrichment device is configured to withstand between about 1 and about 4 bar of absolute pressure. In some embodiments, the enrichment device is configured to withstand between about 2 and about 4 bar of absolute pressure. In some embodiments, the enrichment device is configured to withstand between about 3 and about 4 bar of absolute pressure. In some embodiments, the enrichment device is configured to withstand less than or equal to about 6 bar of absolute pressure. In some embodiments, the enrichment device is configured to withstand less than or equal to about 4 bar of absolute pressure.

[0285] In some embodiments, the filter may be characterized in terms of its nominal molecular weight limit (NMWL). As described herein, a filter having a nominal molecular weight limit permits passage of molecules having a molecular weight less than or equal to the NMWL value and block passage of molecules having a molecular weight greater than the NMWL value. In some embodiments, the filter has a nominal molecular weight limit of less than or equal to 100 kDa, less than or equal to about 80 kDa, less than or equal to about 75 kDa, less than or equal to about 60 kDa, less than or equal to about 50 kDa, less than or equal to about 40 kDa, less than or equal to about 25 kDa, or less than or equal to about 20 kDa. In other embodiments, the filter has a nominal molecular weight limit of at least about 2 kDa, at least about 5 kDa, at least about 10 kDa, at least about 15 kDa, at least about 20 kDa, at least about 25 kDa, or at least about 50 kDa. In some embodiments, the filter is an ultrafilter having a nominal molecular weight limit between about 2 kDa and about 100 kDa, between about 2 kDa and about 50 kDa, between about 2 kDa and about 10 kDa, between about 5 kDa and about 100 kDa, between about 5 kDa and about 10 kDa, between about 4 kDa and about 10 kDa, or between about 10 kDa and about 100 kDa. In some embodiments, the filter is an ultrafilter less than or equal to about 100 kDa. In some embodiments, the filter is an ultrafilter having a nominal molecular weight limit of at least about 10 kDa. In some embodiments, the filter has a nominal molecular weight limit of less than or equal to about 50 kDa. In some embodiments, the filter has a nominal molecular weight limit of less than or equal to about 30 kDa.

[0286] It should be recognized that the device as described herein may include additional components suitable to enable insertion and / or removal of the filter unit as well as assembly and / or disassembly of the enrichment device, including but not limited to sealing (O) rings, gaskets, clamps, quick release clamps, valves, tubing / hose(s), Swagelok connections, ferrules, etc.

[0287] In some embodiments, the device requires unenriched human breast milk as the sole input. In some embodiments, the device requires unenriched human breast milk and positive air pressure as the sole inputs. In some embodiments, the device does not require the addition of NaOH, HC1, or any other chemical. In some embodiments, the device may process 0.5-2 L of human breast milk per use. In some embodiments, the size of the device allows for easy tabletop assembly and handwashing by the final user, for example by nurses.

[0288] In some embodiments, the device has an operation time of about 20 hours per filtration. In some embodiments, the device has an operation time of about 15 hours to about 30 hours per filtration. In some embodiments, the device has an operation time of about 15 hours to about 25 hours per filtration.

[0289] In some embodiments, the device is configured to maintain a temperature of at least about 0 degrees Celsius, at least about 2 degrees Celsius, at least about 4 degrees Celsius, at least about 5 degrees Celsius, at least about 7 degrees Celsius or at least about 10 degrees Celsius. In other embodiments, the device is configured to maintain a temperature of less than or equal to about 16 degrees Celsius, less than or equal to about 15 degrees Celsius, less than or equal to about 14 degrees Celsius, less than or equal to about 12 degrees Celsius, or less than or equal to about 10 degrees Celsius. In some embodiments, the device is configured to maintain a temperature of between about 0 and about 16 degrees Celsius, between about 0 and about 10 degrees Celsius, between about 4 and about 10 degrees Celsius, between about 4 and about 16 degrees Celsius, between about 5 and about 16 degrees Celsius, between about 5 and about 10 degrees Celsius, between about 10 and about 16 degrees Celsius, or between about 10 and about 15 degrees Celsius. In some embodiments, the device is configured to maintain a temperature of between 0 and 10 degrees Celsius. In some embodiments, the device is configured to maintain a temperature of between 0 and 16 degrees Celsius. In some embodiments, the device isconfigured to maintain a temperature of between 5 and 10 degrees Celsius. In some embodiments, the device is configured to maintain a temperature of about 16 degrees Celsius. In some embodiments, the device is configured to maintain a temperature of less than about 16 degrees Celsius. Regulations may require a range of 2 to 4 degrees Celsius to prevent bacterial growth.

[0290] In some embodiments, the present disclosure provides a device as described herein and instructions for use, including but not limited to assembly, disassembly, operation, cleaning, autoclaving, and maintenance, quantifying an amount of protein and / or fat, modelling carbohydrates and total energy, calculating feeding regimes and fortification of milk, etc.

[0291] In some variations, the device as provided herein may be capable of automated operation, with minimal initial preparation (e.g., assembly of filtration units, loading of source human breast milk, sealing of filtration units) and initiation by a user. In some embodiments, the device as provided herein is capable of or configured for automated operation.

[0292] In some embodiments, the device comprises an interface capable of providing a visual output. In some embodiments, the device comprises an internal operating system. In some embodiments, the interface capable of showing progress or status of protein enrichment. In some embodiments, the device is connected to an external operating system.

[0293] In some embodiments, the device as provided herein may also be equipped with one or more sensors. In some embodiments, the enrichment device is equipped with one or more pressure gauges. In some embodiments, the enrichment device is equipped with one or more thermometers. In some embodiments, the enrichment device is equipped with one or more optical sensors. In some embodiments, the enrichment device is equipped with one or more alert features. In some embodiments, the enrichment device is equipped with one or more audible alarms. In some embodiments, the enrichment device is equipped with one or more visual alerts. In some embodiments, the enrichment device is equipped with one or more safety or interlock mechanisms to ensure that the device remains within the operation parameters, e.g., hermetic sealing, pressurization, temperature, etc. In some embodiments, the device further comprises one or more sensors. In some embodiments, the device comprises one or more sensors capable ofmonitoring the quantity of liquid present in the device and / or one or more reservoirs and / or the air pressure and / or temperature in the device.

[0294] In some aspects, provided is method for obtaining a protein- and fat-enriched fraction from unenriched breast milk, comprising: passing a sample of unenriched breast milk through a filtration unit comprising a filter; and collecting a sample of enriched milk from a protein and fat enriched retentate.

[0295] In some embodiments, the method further comprises monitoring one or more filtration parameters while passing the sample of unenriched milk through the filter. In some embodiments, the method further comprises monitoring one or more filtration parameters selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of a protein and fat reduced filtrate.

[0296] In some embodiments, the method comprises monitoring an air pressure inside the filtration unit. In some embodiments, the method comprises monitoring a stirring speed inside the filtration unit. In some embodiments, the method comprises monitoring a temperature around the filtration unit. In some embodiments, the method comprises monitoring an amount of time that has passed. In some embodiments, the method comprises monitoring a weight reading of the protein and fat enriched retentate. In some embodiments, the method comprises monitoring a weight reading of a protein and fat reduced filtrate. In some embodiments, the method comprises monitoring an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit. In some embodiments, the method comprises monitoring an air pressure inside the filtration unit and a stirring speed inside the filtration unit. In some embodiments, the method comprises monitoring an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a weight reading of the protein and fat enriched retentate. In some embodiments, the method comprises monitoring an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a weight reading of a protein and fat reduced filtrate.

[0297] In some embodiments, one or more filtration parameters are monitored using a first program comprising a first set of executable instructions. In some embodiments, the first program comprising a first set of executable instructions is configured to control one or more filtration parameters selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit. In some embodiments, the first program comprising a first set of executable instructions is configured to control an air pressure inside the filtration unit. In some embodiments, the first program comprising a first set of executable instructions is configured to control a stirring speed inside the filtration unit. In some embodiments, the first program comprising a first set of executable instructions is configured to control a temperature around the filtration unit. In some embodiments, the first program comprising a first set of executable instructions is configured to control an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit. In some embodiments, the first program is associated with an operating system having a user interface.IV. METHODS OF PREPARING HUMAN MILK FORTIFIER

[0298] In some aspects, a method for preparing human milk fortifier is provided. In some embodiments, the method comprises passing unenriched breast milk through a filter. In some embodiments, the method comprises producing a fat- and protein-enriched retentate. In some embodiments, the method comprises collecting a fat- and protein-enriched retentate.

[0299] In some embodiments, the temperature of the unenriched breast milk is not raised above 25 °C. In some embodiments, the temperature of the unenriched breast milk is not raised above 16 °C. In some embodiments, the temperature of the unenriched breast milk is between 5 °C and 16 °C. In some embodiments, the temperature of the unenriched breast milk is between 2 °C and 4 °C.

[0300] In some embodiments, the method comprises agitating or stirring the unenriched breast milk.

[0301] In some embodiments, the method further comprises determining the dilution ratio of the enriched milk to the unenriched breast milk. In some embodiments, the determination is foruse in feeding a neonate. In some embodiments, the determination is based on a final feeding volume and / or individual growth rate of the neonate.

[0302] In some embodiments, a total volume of the human milk fortifier obtained from an initial volume of the human or animal milk is less than a fifth of the initial volume. In some embodiments, the volume of the human milk fortifier is between 10 and 20 times less than the volume of the unenriched breast milk. In some embodiments, the protein and fat concentration of the human milk fortifier is between 5 and 10 times more than the protein and fat concentration of the unenriched breast milk. In some embodiments, more concentrated milk is better a smaller volume of fortifier may allow protein and fat to be provided in high concentration. More concentrated fortifiers may enable adding smaller volumes of fortifiers to milk.

[0303] In some embodiments, a program comprising a set of executable instructions for quantifying an amount of protein and / or fat in a sample of enriched or unenriched breast milk also comprises a set of executable instructions for determining the dilution ratio of the enriched milk to the unenriched breast milk for obtaining fortified milk.V. HUMAN MILK FORTIFIER COMPOSITIONS AND METHODS OF USE THEREOF

[0304] In some embodiments, the device as provided herein may also provide improved recovery of protein and fat content in the final human milk fortifier, as compared to comparable small or large-scale devices.

[0305] In some aspects, a human milk fortifier composition is provided. In some aspects, the human milk fortifier composition is obtained from or obtainable by a method described above. In some embodiments, the human milk fortifier compositions as provided herein are liquid. In other embodiments, human milk fortifier compositions provided herein may be characterized by a liquid volume or a relative reduction in volume, such as by a concentration factor, as compared to the volume of source unenriched breast milk from which it was obtained.

[0306] In some embodiments, the human milk fortifier compositions as provided herein may be described by one or more components present in the human milk fortifier composition, including but not limited to fat, protein, carbohydrates, and / or water. In some embodiments, thehuman milk fortifier compositions as provided herein may be characterized by the content of one or more components by relative content of a given component per unit weight (for example, per gram or kilogram) or per unit volume (for example, per milliliter or liter) of the total human milk fortifier content. In other embodiments, the human milk fortifier compositions as provided herein may be characterized by the content of one or more components by relative content of a given component as compared to the content of the same component(s) present in the source human breast milk from which the fortifier composition was obtained or derived.

[0307] In some embodiments, human milk fortifier composition as provided herein may be characterized by its protein content. In contrast to large-scale operations using pooled human breast milk in industrial scale systems, which result in significant losses of protein, sometimes up to 80% or higher, the devices and methods of the present disclosure allow for higher recovery of protein content — that is, higher protein yield — from the source human breast milk.

[0308] In some embodiments, the device and method of the present disclosure allow for recovery of at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, or at least about 50% protein content from the unenriched human breast milk. In some embodiments, the composition retains over 50% of the protein mass of the unenriched human breast milk. In some embodiments, the composition retains over 80% of the protein mass of the unenriched human breast milk. In some embodiments, the composition retains over 90% of the protein mass of the unenriched human breast milk.

[0309] In some embodiments, the device and method of the present disclosure allow for recovery of at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, or at least about 50% fat content from the unenriched human breast milk. In some embodiments, the composition retains over 50% of the fat mass of the unenriched human breast milk. In some embodiments, the composition retains over 80% of the fat mass of the unenriched human breast milk. In some embodiments, the composition retains over 90% of the fat mass of the unenriched human breast milk.

[0310] In some embodiments, the human milk fortifier composition as provided herein may be characterized by the distribution or profile of protein classes or individual proteins present in the overall protein content.

[0311] In some embodiments, human milk fortifier composition as provided herein may be characterized by its immunological activity or the presence of immunological proteins. In some embodiments, the composition retains full or partial immunoactivity of the source unenriched breast milk. In some embodiments, wherein the immunoactivity provides protection against one or more medical conditions. In some embodiments, the immunoactivity protects against allergy, late-onset sepsis, necrotizing enterocolitis, or a combination thereof.

[0312] In some aspects, a method for increasing neonate weight is provided. In some embodiments, the method provides one or more improved clinical outcomes. In some embodiments, the improved clinical outcomes may include short and / or long term benefits. In certain embodiments, such improved clinical outcomes include improved neurodevelopmental outcomes, improved growth velocity including rate of weight gain, incremental linear growth, incremental rate of head circumference growth, reduced length of stay in the hospital and a reduction of the days of parenteral nutrition. In some embodiments, the one or more improved clinical outcomes is selected from reduced incidence and / or severity of feeding intolerance, reduced incidence and / or severity of sepsis, reduced incidence and / or severity of necrotizing enterocolitis (NEC), reduced incidence and / or severity of wound infections and / or wound dehiscence. In some embodiments, the method comprises feeding a composition according to the above description to a neonate. In some embodiments, the neonate does not experience unwanted or dangerous side effects associated with heterologous fortifiers obtained from animal milk. In some aspects, a human milk fortifier composition for use in increasing neonate weight is provided.

[0313] In some embodiments, the neonate is a full-term neonate. In some embodiments, the full-term neonate was born after at least 37 weeks of gestation. In some embodiments, the neonate has is a preterm neonate. In some embodiments, a preterm neonate was bom less than 37 weeks of gestation.

[0314] In other embodiments, the neonate is a neonate having very low birth weight (VLBW). In some embodiments, the neonate has a birth weight of less than or equal to about 1.5 kilograms. In some embodiments, the neonate has a weight of less than or equal to about 2.5kilograms. In some embodiments, the neonate has a weight of less than or equal to about 3.5 kilograms.

[0315] In some embodiments, the diet of the neonate does not comprise non-human milk products. In some embodiments, the neonate is regularly fed the human milk fortifier for at least about one month, at least about two months, or at least about three months.

[0316] In some embodiments, the human milk fortifier composition is produced from the breast milk of the neonate’s own mother. In some embodiments, the human breast milk of the composition is not produced by the mother of the neonate. In some embodiments, human milk fortifier composition is produced from the breast milk of a donor, who is not the neonate’s own mother.

[0317] In some embodiments, the enriched milk is pasteurized before being aliquoted for dilution with unenriched milk. In some embodiments, the enriched milk is pasteurized before being aliquoted for dilution with unenriched milk for hygiene.

[0318] In some embodiments, the neonate is fed between about five and about ten doses of human milk fortifier per day. In some embodiments, the method comprises freezing the human milk fortifier. In some embodiments, the method comprises freezing the human milk fortifier and thawing the human milk fortifier. In some embodiments, the method comprises feeding the human milk fortifier to the neonate within 48 hours if the protein-enriched retentate is stored at about 4 °C. In some embodiments, the method comprises freezing the human milk fortifier, thawing the human milk fortifier, and feeding the human milk fortifier to the neonate. In some embodiments, the human milk fortifier is not frozen and thawed. In some embodiments, the human milk fortifier is prepared between two and five times during the total time of infant hospitalization after birth.EXAMPLES

[0319] The presently disclosed subject matter will be better understood by reference to the following Examples, which are provided as exemplary of the invention, and not by way of limitation.Example 1: Preparation of Human Milk Origin Fortifier Composition

[0320] The present example details an exemplary method for the preparation of a human milk fortifier composition or enriched milk.

[0321] Various human origin milk fortifier compositions were prepared from unenriched milk samples using the described enrichment device with a 30 kDa PES ultrafilter.

[0322] The unenriched breast milk was measured using a MIR-spectrometer (sample “unenriched milk” in Table 1. The unenriched breast milk (650 ml total volume) was then filtered through a 30 kDa PES ultrafilter at 4 °C at 4 bars and a maximum stirring speed of 200 rpm. The pressure was maintained at about 4 bar for the initial 10 hours of the enrichment process and was subsequently decreased to about 0.5 bar once the residual volume of the retentate of the filtration unit was about 200 ml. The enrichment process was stopped when the remaining volume of retentate was about 75 ml. The total filtration time was around 24 hours, and the volume of the enriched milk was reduced by about 9.3 times from the unenriched milk.

[0323] The efficiency of protein recovery was about 95%, and the efficiency of fat recovery was about 90%. The carbohydrate content was not enriched during the enrichment process because this macronutrient typically does not need to be fortified for preterm infants.Table 1. MIR-based measurement of Protein, Fat and Carbohydrate Concentration (g / 100 ml) and total energy’s content (kcal / 100 ml)

[0324] Table 2 (below), a table for feeding neonates, was established from the values in Table 1.Example 3: Sample Neonate Treatment Regime

[0325] After enrichment, it is recommended to aliquot the total volume (about 50 to 100 ml) of enriched milk into smaller aliquots of about 10 ml each. The 10 ml aliquot is the recommended average daily amount of enriched milk to be diluted with unenriched human milk in various ratios depending upon the daily nutritional needs of the neonate.

[0326] The daily portion of the enriched milk consumed by a preterm neonate can vary from about 3 to about 10 ml and depends upon the desired weight gain, gestational age, daily milk consumption, and health status of the neonate.

[0327] The dosage of the enriched milk and the ratio of its dilution by unenriched milk can therefore be adapted to the individual requirements of the neonate. In early stages, when a neonate cannot consume large volumes of milk, the role of fortification or enrichment is very high. At these stages, the concentration of fat and protein should be higher to meet the nutritional and growth needs of the neonate. In this case, smaller dilution factors of the enriched milk by unenriched milk (e.g., about a 1 :4 ratio of the enriched milk to the unenriched milk) can be chosen.

[0328] In later stages, when the neonate begins to consume a larger volume of milk, the role of fortification is decreased as the required daily amount of protein and fat required for optimal growth can be obtained from less fortified milk. In these cases, higher dilution factors of the enriched milk by unenriched milk (e.g., about a 1 :9 ratio or even up to a 1 :80 ratio of the enriched milk to the unenriched milk) can be chosen. The role of protein and fat fortification gradually decreases with the gestational age of the neonate.

[0329] A sample treatment regime is shown in Table 3.Table 2. Total daily macronutrient amount (in g / kg) provided by enriched milk for different groups of VLBW (very -low birth weight) neonates.*Macronutrient data are the same as in Table 1.

[0330] Figures, numbers, amounts, and / or ranges described herein may be described with respect to specific examples. Unless otherwise specified, it should be understood that disclosures describing figures, numbers, amounts, and / or ranges should include those figures, numbers, amounts, and / or ranges specifically noted and those figures, numbers, amounts, and / or ranges that are about equivalent thereto (e.g., within + / - 10%, 5%, 2%, or 1%).

[0331] All publications, patent applications, patents, and other references mentioned herein are expressly incorporated by reference in their entireties, to the same extent as if each were incorporated by reference individually.

[0332] It is to be understood that, while the disclosure has been described in conjunction with the above embodiments, the foregoing description and examples are intended to illustrate and not limit the scope of the disclosure. Other aspects, advantages and modifications within thescope of the disclosure will be apparent to those skilled in the art to which the disclosure pertains.

[0333] The following aspects are part of the invention:1. A system, configured to enrich unenriched breast milk and quantify an amount of protein and / or fat in unenriched or enriched breast milk, comprising: an enrichment device, configured to obtain a protein and fat enriched fraction from the unenriched breast milk, wherein the enrichment device comprises: a filtration unit comprising an ultrafilter; and a reservoir, wherein the filtration unit is configured to separate a protein and fat enriched retentate from a protein and fat reduced filtrate; a first program comprising a first set of executable instructions configured to control one or more parameters of the enrichment device; a UV measurement head, configured to measure UV absorbance of a sample comprising unenriched or enriched breast milk; and a second program comprising a second set of executable instructions configured to quantify the amount of protein and / or fat in unenriched or enriched breast milk.2. The system of item 1, wherein the ultrafilter has a nominal molecular weight limit of less than or equal to about 30 kDa.3. The system of item 1 or 2, wherein the enrichment device further comprises a second reservoir configured to receive the protein and fat reduced filtrate from the filtration unit.4. The system of item 3, wherein the enrichment device further comprises a weight sensor, wherein:the weight sensor is associated with the filtration unit and is configured to provide a real-time weight reading of the protein and fat enriched retentate; or the weight sensor is associated with the second reservoir and is configured to provide a real-time weight reading of the protein and fat reduced filtrate.5. The system of any one of items 1-4, wherein the enrichment device further comprises one or more pressure valves connected with the filtration unit, wherein one or more pressure valves are configured to provide a positive air pressure to the filtration unit.6. The system of item 5, wherein the enrichment device further comprises one or more pressure sensors integrated each of the one or more pressure valves respectively, wherein the pressure sensors are configured to monitor the air pressure inside the filtration unit.7. The system of item 5 or 6, wherein one or more pressure valves are configured to release air and decrease an air pressure inside the filtration unit.8. The system of item 1, wherein the enrichment device is configured to transmit one or more parameters to the first program, wherein the one or more parameters the enrichment device is configured to transmit are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of the protein and fat reduced filtrate.9. The system of item 8, wherein the one or more controllable parameters of the enrichment device are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit.10. The system of item 9, wherein the first program comprising a first set of executable instructions is configured to change an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and / or a temperature around the filtration unit upon the enrichment device transmitting a particular weight reading of the protein and fat enriched retentate or a particular weight reading of the protein and fat reduced filtrate.11. The system of any one of items 8-10, wherein the first program is associated with an operating system having a user interface.12. The system of any one of items 1-11, wherein the UV measurement head comprises: a LED light source configured to emit UV light; a sample chamber configured to hold the sample; one or more lens configured to focus the emitted UV light; and a UV spectrometer configured to measure UV absorbance of the sample.13. The system of any of items 1-12, wherein the second program is configured to quantify the amount of protein and / or fat in the unenriched or enriched breast milk from the UV absorbance of the sample.14. The system of item 13, wherein the second program is associated with an operating system having a user interface.15. The system of item 1, wherein the enrichment device and the UV measurement head are separate units.16. The system of item 1, wherein the first and second programs are associated with the same operating system.17. The system of item 1, wherein the first program is associated with a first operating system integrated into the enrichment device, and the second program is associated with a second operating system that is external to the UV measurement head.18. A device that is a UV measurement head for quantifying the amount of protein and / or fat in a sample, wherein the sample comprises unenriched or enriched breast milk, wherein the device comprises: a LED light source configured to transmit UV light; a sample chamber configured to hold the sample;one or more lens configured to focus the emitted UV light; and a UV spectrometer configured to measure UV absorbance of the sample.19. The device of item 18, wherein the UV spectrometer is calibrated using air or water.20. The device of item 18 or 19, wherein the sample chamber is a cuvette comprising a cuvette cover and a cuvette bottom, wherein the cuvette cover and cuvette bottom each comprise quartzglass.21. The device of item 20, wherein the cuvette cover and cuvette bottom are separated by less than or equal to about 0.5 mm or less than or equal to about 0.2 mm when the sample chamber is closed.22. The device of any one of items 18-21, wherein the device is powered by a battery.23. The device of any one of items 18-22, wherein the device is configured to transmit the UV absorbance of the sample to a program comprising a set of executable instructions for converting the UV absorbance of the sample to a UV absorbance spectrum.24. The device of any one of items 18-23, wherein the device is configured to transmit the UV absorbance of the sample to a program comprising a set of executable instructions for quantifying the amount of protein and / or fat in the sample from the UV absorbance of the sample.25. The device of item 23 or 24, wherein the program is configured to calculate a total energy value of the sample from the quantified amount of protein and fat and an estimated amount of carbohydrates in the sample.26. The device of any one of items 23-25, wherein the device further comprises a magnetic safety locker and a lid, wherein the lid comprises the LED light source, and wherein the program is configured to prevent the LED light source from emitting UV light when the lid is open.27. The device of any one of items 23-26, wherein the program is associated with an operating system having a user interface.28. A device that is an enrichment device, configured to obtain a protein and fat enriched fraction from unenriched breast milk, wherein the device comprises: a filtration unit comprising an ultrafilter and a reservoir, wherein the filtration unit is configured to separate a protein and fat enriched retentate from a protein and fat reduced filtrate.29. The device of item 28, wherein the ultrafilter has a nominal molecular weight limit of less than or equal to about 30 kDa.30. The device of item 28 or 29, wherein the enrichment device further comprises a second reservoir configured to receive the protein and fat reduced filtrate from the filtration unit.31. The device of any one of items 28-31, wherein the enrichment device further comprises a weight sensor, wherein: the weight sensor is associated with the filtration unit and is configured to provide a real-time weight reading of the protein and fat enriched retentate; or the weight sensor is associated with the second reservoir and is configured to provide a real-time weight reading of the protein and fat reduced filtrate.32. The device of any one of items 28-31, wherein the enrichment device further comprises one or more pressure valves connected with the filtration unit, wherein one or more pressure valves are configured to provide a positive air pressure to the filtration unit.33. The device of item 32, wherein the enrichment device further comprises one or more pressure sensors integrated each of the one or more pressure valves respectively, wherein the pressure sensors are configured to monitor the air pressure inside the filtration unit.34. The device of item 33, wherein one or more pressure valves are configured to release air and decrease an air pressure inside the filtration unit automatically.35. The device of any one of items 28-34, wherein the enrichment device is configured to transmit one or more parameters to a program comprising a set of executable instructions for controlling one or more controllable parameters of the enrichment device.36. The device of item 35, wherein the one or more parameters the enrichment device is configured to transmit are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of the protein and fat reduced filtrate.37. The device of item 35 or 36, wherein the one or more controllable parameters of the enrichment device are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit.38. The device of item 37, wherein the program comprising a set of executable instructions is configured to change an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and / or a temperature around the filtration unit upon the enrichment device transmitting a particular weight reading of the protein and fat enriched retentate or a particular weight reading of the protein and fat reduced filtrate.39. The device of any one of items 35-38, wherein the program is associated with an operating system having a user interface.40. The device of item 39, wherein the operating system is external to the enrichment device.41. The device of item 39, wherein the operating system is integrated into the enrichment device.42. A method for enriching breast milk and quantifying an amount of protein and / or fat in unenriched or enriched breast milk, comprising: passing a sample of unenriched milk through a filtration unit comprising a filter; collecting a sample of enriched milk from a protein and fat enriched retentate; illuminating at least one of a sample comprising unenriched milk and a sample comprising enriched milk;measuring UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk, wherein the UV absorbance is measured using a UV measurement head; and quantifying an amount of protein and / or fat in said at least one of said sample comprising unenriched milk and said sample comprising enriched milk using said UV absorbance.43. The method of item 42, wherein the method comprises illuminating an unenriched milk sample, measuring UV absorbance of said unenriched milk sample, and quantifying an amount of protein and / or fat in said unenriched milk sample using said UV absorbance.44. The method of item 42, wherein the method comprises illuminating an enriched milk sample, measuring UV absorbance of said enriched milk sample, and quantifying an amount of protein and / or fat in said enriched milk sample using said UV absorbance.45. The method of item 42, wherein the method comprises illuminating an unenriched milk sample, measuring a first UV absorbance wherein the first UV absorbance is the absorbance of said unenriched milk sample, quantifying an amount of protein and / or fat in said unenriched milk sample using said first UV absorbance, illuminating an enriched milk sample, measuring a second UV absorbance wherein the second UV absorbance is the absorbance of said enriched milk sample, and quantifying an amount of protein and / or fat in said enriched milk sample using said second UV absorbance.46. The method of any one of items 42-45, further comprising monitoring one or more filtration parameters while passing the sample of unenriched milk through the filter.47. The method of item 46, further comprising monitoring one or more filtration parameters selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of a protein and fat reduced filtrate.48. The method of item 47, wherein one or more filtration parameters are monitored using a first program comprising a first set of executable instructions.49. The method of item 48, wherein the first program comprising a first set of executable instructions is configured to control one or more filtration parameters selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit.50. The method of item 48 or 49, wherein the first program is associated with an operating system having a user interface.51. The method of any one of items 42-50, further comprising diluting the sample of unenriched breast milk or the sample of enriched breast milk to obtain the sample comprising unenriched breast milk or the sample comprising enriched breast milk.52. The method of any one of items 42-51, further comprising homogenizing the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk.53. The method of any one of items 42-52, further comprising breaking large micelles and aggregates in the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk.54. The method of any one of items 42-53, wherein the UV measurement head is configured to transmit the UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk to a second program comprising a second set of executable instructions configured to quantify the amount of protein and / or fat in the at least one sample comprising unenriched milk or sample comprising enriched milk.55. The method of item 54, wherein the second program is associated with an operating system having a user interface.56. The method of item 42, wherein one or more filtration parameters are monitored using a first program comprising a first set of executable instructions, the UV measurement head is configured to transmit the UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk to a second program comprising a second set of executable instructions configured to quantify the amount of protein and / or fat inthe at least one sample comprising unenriched milk or said sample comprising enriched milk, and the first program and the second program are associated with the same operating system.57. The method of any one of items 54-56, wherein the method further comprises converting the UV absorbance of the sample comprising unenriched milk or the sample comprising enriched milk into a UV absorbance spectrum.58. The method of item 57, further comprising comparing the UV absorbance spectrum with a reference curve that is a UV absorbance spectrum of water or air.59. A method for quantifying an amount of protein and / or fat in unenriched or enriched breast milk, comprising: illuminating at least one of a sample comprising unenriched milk and a sample comprising enriched milk; measuring UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk, wherein the UV absorbance is measured using a UV measurement head; and quantifying an amount of protein and / or fat in said at least one of said sample comprising unenriched milk and said sample comprising enriched milk using said UV absorbance.60. The method of item 59, further comprising diluting the sample of unenriched breast milk or the sample of enriched breast milk to obtain the sample comprising unenriched breast milk or the sample comprising enriched breast milk.61. The method of item 59 or 60, further comprising homogenizing the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk.62. The method of any one of items 58-60, further comprising breaking large micelles and aggregates in the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk.63. The method of any one of items 58-61, wherein the UV measurement head is configured to transmit the UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk to a program comprising a set of executable instructions configured to quantify the amount of protein and / or fat in the at least one sample comprising unenriched milk or said sample comprising enriched milk.64. The method of item 63, wherein the program is associated with an operating system having a user interface.65. The method of item 64, wherein the method further comprises converting the UV absorbance of the sample comprising unenriched milk or the sample comprising enriched milk into a UV absorbance spectrum.66. The method of item 65, further comprising comparing the UV absorbance spectrum with a reference curve that is a UV absorbance spectrum of water or air.67. A method for obtaining a protein- and fat-enriched fraction from unenriched breast milk, comprising: passing a sample of unenriched breast milk through a filtration unit comprising a filter; and collecting a sample of enriched milk from a protein and fat enriched retentate.68. The method of item 67, further comprising monitoring one or more filtration parameters while passing the sample of unenriched milk through the filter.69. The method of item 68, further comprising monitoring one or more filtration parameters selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of a protein and fat reduced filtrate.70. The method of item 69, wherein one or more filtration parameters are monitored using a program comprising a set of executable instructions.71. The method of item 70, wherein the program comprising a set of executable instructions is configured to control one or more filtration parameters selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit.72. The method of item 70 or 71, wherein the program is associated with an operating system having a user interface.

Claims

CLAIMSWhat is claimed is:

1. A system for enriching unenriched breast milk and quantifying an amount of protein and / or fat in the enriched breast milk, comprising: an enrichment device, configured to obtain a protein and fat enriched fraction from the unenriched breast milk, wherein the enrichment device comprises: a filtration unit comprising an ultrafilter for separating a protein and fat enriched retentate from a protein and fat reduced filtrate; and one or more processors and memory storing computer-readable code comprising a first set of executable instructions which, when executed by the one or more processors, control one or more controllable parameters of the enrichment device; a UV measurement head, configured to measure UV absorbance of a sample comprising the unenriched breast milk or enriched breast milk created using the retentate from the enrichment device; and wherein the instructions, when executed, cause the system to quantify the amount of protein and / or fat in the unenriched breast milk or the enriched breast milk based at least in part on the measured UV absorbance of the unenriched or enriched breast milk.

2. The system of claim 1, wherein the ultrafilter has a nominal molecular weight limit of less than or equal to about 30 kDa.

3. The system of claim 1 or 2, wherein the enrichment device further comprises a waste reservoir configured to receive the protein and fat reduced filtrate from the filtration unit.

4. The system of claim 3, wherein the enrichment device further comprises a weight sensor, wherein: the weight sensor is associated with the filtration unit and is configured to provide a real-time weight reading of the protein and fat enriched retentate; orthe weight sensor is associated with the waste reservoir and is configured to provide a real-time weight reading of the protein and fat reduced filtrate.

5. The system of any one of claims 1-4, wherein the enrichment device further comprises one or more pressure valves connected with the filtration unit, wherein one or more pressure valves are configured to provide a positive air pressure to the filtration unit.

6. The system of claim 5, wherein the enrichment device further comprises one or more pressure sensors associated with each of the one or more pressure valves respectively, wherein the pressure sensors are configured to monitor the air pressure inside the filtration unit.

7. The system of claim 5 or 6, wherein one or more pressure valves are configured to release air and decrease an air pressure inside the filtration unit.

8. The system of any one of claims 1-7, wherein the enrichment device is configured to transmit one or more parameters to the one or more processors, wherein the one or more parameters the enrichment device is configured to transmit are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of the protein and fat reduced filtrate.

9. The system of claim 8, wherein the one or more controllable parameters of the enrichment device are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit.

10. The system of claim 9, wherein controlling the one or more controllable parameters of the enrichment device comprises, in response to the enrichment device transmitting a weight reading of the protein and fat enriched retentate or a weight reading of the protein and fat reduced retentate, changing an air pressure inside the filtration unit, changing a stirring speed inside the filtration unit, and / or changing a temperature around the filtration unit.

11. The system of any one of claims 8-10, wherein the instructions cause the system to display a user interface comprising an indication of the one or more controllable parameters of the enrichment device.

12. The system of any one of claims 1-11, wherein the UV measurement head comprises: an LED light source configured to emit UV light; a sample chamber configured to hold the sample; one or more lenses configured to focus the emitted UV light; a UV spectrometer configured to measure UV absorbance of the sample; and a cooling chamber configured to maintain a constant temperature during a measurement such that heating of the sample is mitigated, wherein the cooling chamber is provided in thermal communication with a sample cuvette.

13. The system of any of claims 1-12, wherein quantifying the amount of protein and / or fat in the unenriched or enriched breast milk is based on the measured UV absorbance of the sample, including at least one of a first UV absorbance of the sample at a first wavelength range associated with protein content and a second UV absorbance of the sample at a second wavelength range associated with fat content.

14. The system of claim 13, wherein the user interface comprises an indication of the quantified amount of protein and / or fat.

15. The system of any one of claims 1-14, wherein the enrichment device and the UV measurement head are separate units.

16. The system of any one of claims 1-15, wherein the instructions further cause the system to, based on the quantification of the amount of protein and / or fat in the unenriched breast milk, automatically control the one or more controllable parameters of the enrichment device.

17. The system of any one of claims 1-16, wherein a portion of the instructions for controlling the parameters of the enrichment device are associated with a first operating system integrated into the enrichment device, and wherein a portion of the instructions for quantify the amount of protein and / or fat in unenriched or enriched breast milk is associated with a second operating system that is external to the UV measurement head.

18. The device of any one of claims 1-17, wherein the quantification of the enriched breast milk is performed without: performing chemical treatment of the enriched breast milk orunenriched breast milk, heating the enriched breast milk or unenriched breast milk, centrifuging the enriched breast milk or unenriched breast milk, or sonicating the enriched breast milk or unenriched breast milk.

19. The device of any one of claims 1-18, wherein an efficiency of protein recovery in the enriched breast milk is 90% or more of the total protein content of the unenriched breast milk.

20. The device of any one of claims 1-19, wherein an efficiency of fat recovery in the enriched breast milk is 90% or more of the total fat content of the unenriched breast milk.

21. The device of any one of claims 1-20, wherein quantifying the amount of protein and / or fat in the unenriched or enriched breast milk is based on the measured UV absorbance of the sample and comprises: applying a first digital filter to data representing the UV absorbance to determine the amount of protein, wherein the first digital filter uses a window of a first size and a polynomial of one order, and the first derivative; and applying a second digital filter to the data representing the UV absorbance to determine the amount of fat, wherein the second digital filter uses a window of the first size and a polynomial of another order different than the order used for the first digital filter, and no derivative.

22. The device of any one of claims 1-21, wherein quantifying the amount of protein and / or fat in the unenriched or enriched breast milk is based on the measured UV absorbance of the sample and comprises processing a signal from the UV measurement head using a Partial Least Square (PLS) method.

23. The device of claim 22, wherein the system is trained with cross-value prediction to apply the PLS method.

24. The device of any one of claims 1-23, wherein the one or more processors determine that the enrichment process is complete in response to the enrichment device transmitting a weight reading of the protein and fat enriched retentate or a weight reading of the protein and fat reduced filtrate.

25. The device of any one of claims 1-24, wherein the filtration unit comprises a bottom interior surface comprising a plurality of grooves arranged to direct flow of liquid to a center hole formed in the bottom interior surface.

26. The device of any one of claims 1-25, wherein a temperature of the sample in the UV measurement during measurement is less than or equal to 25 °C.

27. The device of any one of claims 1-26, wherein the sample in the UV measurement head is not pre-heated before measurement.

28. A UV measurement head for quantifying the amount of protein and / or fat in a sample, wherein the sample comprises unenriched or enriched breast milk, wherein the UV measurement head comprises: an LED light source configured to emit UV light; a sample chamber configured to hold the sample; one or more lenses configured to focus the emitted UV light; and a UV spectrometer configured to measure UV absorbance of the sample. a cooling chamber configured to maintain a constant temperature during a measurement such that heating of the sample is prevented, wherein the cooling chamber is provided in thermal communication with a sample cuvette.

29. The UV measurement head of claim 28, wherein the UV spectrometer is calibrated using air or water.

30. The UV measurement head of claim 28 or 29, wherein the sample chamber is a cuvette comprising a cuvette cover and a cuvette bottom, wherein the cuvette cover and cuvette bottom each comprise quartz-glass.

31. The UV measurement head of claim 30, wherein the cuvette cover and cuvette bottom are separated by less than or equal to about 0.5 mm or less than or equal to about 0.2 mm when the sample chamber is closed.

32. The UV measurement head of any one of claims 30-31, wherein the UV measurement head is powered by a battery.

33. The UV measurement head of any one of claims 30-32, wherein the UV measurement head is configured to transmit data indicating the UV absorbance of the sample to one or more processors configured to execute a set of executable instructions for converting the UV absorbance of the sample to a UV absorbance spectrum.

34. The UV measurement head of any one of claims 30-33, wherein the UV measurement head is configured to transmit data indicating the UV absorbance of the sample to one or more processors configured to execute a set of executable instructions for quantifying the amount of protein and / or fat in the sample based on the UV absorbance of the sample.

35. The UV measurement head of claim 33 or 34, wherein the instructions cause the system to model a total carbohydrate content and predict a total energy value of the sample based on the quantified amount of protein and fat and the modeled amount of carbohydrates in the sample.

36. The UV measurement head of any one of claims 33-35, wherein the UV measurement head comprises a magnetic safety locker and a lid, wherein the lid comprises the LED light source, and wherein the instructions cause the LED light source to not emit UV light when the lid is open.

37. The UV measurement head of any one of claims 33-36, wherein the instructions cause the system to display a user interface .

38. An enrichment device, configured to obtain a protein and fat enriched fraction from unenriched breast milk, wherein the device comprises: a filtration unit comprising an ultrafilter, wherein the filtration unit is configured to separate a protein and fat enriched retentate from a protein and fat reduced filtrate.

39. The enrichment device of claim 38, wherein the ultrafilter has a nominal molecular weight limit of less than or equal to about 30 kDa.

40. The enrichment device of claim 38 or 39, wherein the enrichment device further comprises a waste reservoir configured to receive the protein and fat reduced filtrate from the filtration unit.

41. The enrichment device of any one of claims 38-40, wherein the enrichment device further comprises a weight sensor, wherein: the weight sensor is associated with the filtration unit and is configured to provide a real-time weight reading of the protein and fat enriched retentate; or the weight sensor is associated with the waste reservoir and is configured to provide a real-time weight reading of the protein and fat reduced filtrate.

42. The enrichment device of any one of claims 38-41, wherein the enrichment device further comprises one or more pressure valves connected with the filtration unit, wherein one or more pressure valves are configured to provide a positive air pressure to the filtration unit.

43. The enrichment device of any one of claims 38-42, wherein the enrichment device further comprises one or more pressure sensors associated with each of the one or more pressure valves respectively, wherein the pressure sensors are configured to monitor the air pressure inside the filtration unit.

44. The enrichment device of claim 43, wherein one or more pressure valves are configured to release air and decrease an air pressure inside the filtration unit automatically.

45. The enrichment device of any one of claims 38-44, wherein the enrichment device is configured to transmit one or more parameters one or more processors configured to execute a set of executable instructions stored in memory for controlling one or more controllable parameters of the enrichment device.

46. The enrichment device of claim 45, wherein the one or more transmitted parameters are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of the protein and fat reduced filtrate.

47. The enrichment device of claim 45 or 46, wherein the one or more controllable parameters of the enrichment device are selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit.

48. The enrichment device of claim 47, wherein executing the set of executable instructions causes the device to change an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and / or a temperature around the filtration unit in response to the enrichment device transmitting a weight reading of the protein and fat enriched retentate or a weight reading of the protein and fat reduced filtrate.

49. The enrichment device of any one of claims 41-48, wherein the instructions cause the device to provide an operating system having a user interface.

50. The enrichment device of claim 49, wherein the memory storing the executable instructions providing the operating system is external to the enrichment device.

51. The enrichment device of claim 50, wherein the memory storing the executable instructions providing the operating system is integrated into the enrichment device.

52. A method for enriching breast milk and quantifying an amount of protein and / or fat in unenriched or enriched breast milk, comprising: passing a sample of unenriched milk through a filtration unit comprising a filter; collecting a sample of enriched milk from a protein and fat enriched retentate; illuminating at least one of a sample comprising the unenriched milk and a sample comprising the enriched milk; measuring UV absorbance of said at least one of said sample comprising the unenriched milk and said sample comprising the enriched milk, wherein the UV absorbance is measured using a UV measurement head; and quantifying an amount of protein and / or fat in said at least one of said sample comprising the unenriched milk and said sample comprising the enriched milk based on said UV absorbance.

53. The method of claim 52, wherein the method comprises illuminating an unenriched milk sample, measuring UV absorbance of said unenriched milk sample, and quantifying an amount of protein and / or fat in said unenriched milk sample using said UV absorbance.

54. The method of any one of claims 52-53, wherein the method comprises illuminating an enriched milk sample, measuring UV absorbance of said enriched milk sample, and quantifying an amount of protein and / or fat in said enriched milk sample using said UV absorbance.

55. The method of any one of claims 52-54, wherein the method comprises illuminating an unenriched milk sample, measuring a first UV absorbance wherein the first UV absorbance is the absorbance of said unenriched milk sample, quantifying an amount of protein and / or fat in said unenriched milk sample using said first UV absorbance, illuminating an enriched milk sample, measuring a second UV absorbance wherein the second UV absorbance is the absorbance of said enriched milk sample, and quantifying an amount of protein and / or fat in said enriched milk sample using said second UV absorbance.

56. The method of any one of claims 52-55, further comprising monitoring one or more filtration parameters while passing the sample of unenriched milk through the filter.

57. The method of claim 56, wherein the one or more filtration parameters are selected from the group consisting of: an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of a protein and fat reduced filtrate.

58. The method of claim 57, wherein one or more filtration parameters are monitored using one or more processors executing a first set of executable instructions stored in memory.

59. The method of claim 58, wherein the executable instructions cause the filtration unit to control one or more filtration parameters selected from the group consisting of: an air pressure inside the filtration unit, a stirring speed inside the filtration unit, and a temperature around the filtration unit.

60. The method of claim 58 or 59, wherein the executable instructions are associated with an operating system having a user interface.

61. The method of any one of claims 56-60, further comprising diluting the sample of unenriched breast milk or the sample of enriched breast milk to obtain the sample comprising unenriched breast milk or the sample comprising enriched breast milk.

62. The method of any one of claims 56-61, further comprising homogenizing the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk.

63. The method of any one of claims 56-62, further comprising breaking large micelles and aggregates in the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk.

64. The method of claim 63, wherein breaking large micelles comprises using a vortex mixer at about 100 to about 200 rpm.

65. The method of any one of claims 52-64, wherein: the UV measurement head is configured to transmit the UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk to one or more processors configured to quantify the amount of protein and / or fat in the at least one sample comprising unenriched milk or sample comprising enriched milk.

66. The method of claim 65, wherein executing the executable instructions causes the one or more processors to cause display of a user interface indicating the quantified amount of protein and / or fat in the at least one sample comprising unenriched milk or sample comprising enriched milk.

67. The method of any one of claims 52-66, wherein: one or more filtration parameters are monitored using one or more processors executing a first set of executable instructions stored in memory, the UV measurement head is configured to transmit the UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk to the one or more processors, and executing the executable instructions causes the one or more processors to quantify the amount of protein and / or fat in the at least one sample comprising unenriched milk or said sample comprising enriched milk.

68. The method of any one of claims 60-67, wherein the method further comprises converting the UV absorbance of the sample comprising unenriched milk or the sample comprising enriched milk into a UV absorbance spectrum.

69. The method of claim 68, further comprising comparing the UV absorbance spectrum with a reference curve that is a UV absorbance spectrum of water or air, wherein quantifying the amount of protein and / or fat is based at least in part on the comparison of the UV absorbance spectrum with the reference curve.

70. A method for quantifying an amount of protein and / or fat in unenriched or enriched breast milk, comprising: illuminating at least one of a sample comprising unenriched milk and a sample comprising enriched milk; measuring UV absorbance of said at least one of said sample comprising unenriched milk and said sample comprising enriched milk, wherein the UV absorbance is measured using a UV measurement head; and quantifying an amount of protein and / or fat in said at least one of said sample comprising unenriched milk and said sample comprising enriched milk based on said UV absorbance.

71. The method of claim 70, further comprising diluting the sample of unenriched breast milk or the sample of enriched breast milk to obtain the sample comprising unenriched breast milk or the sample comprising enriched breast milk.

72. The method of claim 70 or 71, further comprising homogenizing the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk.

73. The method of any one of claims 70-72, further comprising breaking large micelles and aggregates in the sample of unenriched breast milk, the sample of enriched breast milk, the sample comprising unenriched breast milk, or the sample comprising enriched breast milk.

74. The method of any one of claims 70-73, wherein the UV measurement head is configured to transmit the UV absorbance of said at least one of said sample comprising unenriched milkand said sample comprising enriched milk to one or more processors configured to execute a set of executable instructions stored in memory, wherein executing the executable instructions causes the one or more processors to quantify the amount of protein and / or fat in the at least one sample comprising unenriched milk or said sample comprising enriched milk.

75. The method of claim 74, wherein executing the executable instructions causes the one or more processors to provide a user interface.

76. The method of claim 75, wherein the method further comprises converting the UV absorbance of the sample comprising unenriched milk or the sample comprising enriched milk into a UV absorbance spectrum.

77. The method of claim 76, further comprising comparing the UV absorbance spectrum with a reference curve that is a UV absorbance spectrum of water or air.

78. A method for obtaining a protein- and fat-enriched fraction from unenriched breast milk, comprising: passing a sample of unenriched breast milk through a filtration unit comprising a filter; and collecting a sample of enriched milk from a protein and fat enriched retentate.

79. The method of claim 78, further comprising monitoring one or more filtration parameters while passing the sample of unenriched milk through the filter.

80. The method of claim 79, further comprising monitoring one or more filtration parameters selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperature around the filtration unit, an amount of time that has passed, a weight reading of the protein and fat enriched retentate, and a weight reading of a protein and fat reduced filtrate.

81. The method of claim 80, wherein one or more filtration parameters are monitored using one or more processors executing instructions stored in memory.

82. The method of claim 81, wherein executing the instructions causes the filtration unit to control one or more filtration parameters selected from the group consisting of an air pressure inside the filtration unit, a stirring speed inside the filtration unit, a temperaturearound the filtration unit, a temperature around a waste container of the filtration unit, a position of a door of the filtration unit, and a position of the waste container.

83. The method of claim 81 or 82, wherein executing the executable instructions causes the one or more processors to provide a user interface.

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