Systems and methods for improved molecule assessment

Abstract

Methods for configuring molecule assessment equipment configured to conduct an automated test that assesses one or more characteristics of a sample under test and systems for implementing the same are provided. The molecule assessment equipment includes a controller that controls an assessment environment in accordance with one or more control parameters. The methods include obtaining sensor data indicative of environmental conditions of a production environment at which the sample under test is to be produced; converting the sensor data to control values of the one or more control parameters; and performing at least one of configuring the controller of the molecule assessment equipment using the control values and presenting the control values via an output device. The molecule assessment equipment is operated to execute the automated test of the sample under test after the controller is configured with the control values.

Description

SYSTEMS AND METHODS FOR IMPROVED MOLECULE ASSESSMENTFIELD OF THE DISCLOSURE

[0001] The present application generally relates to optimizing molecule assessment equipment, and more specifically to configuring molecule assessment equipment in a manner that reflects a production environment for the molecule.BACKGROUND

[0002] Prior to large scale production of biopharmaceutical products (e.g , biotherapeutic proteins), small batches are assessed to ensure that the biopharmaceutical product will maintain stability and / or other characteristics throughout the production process. For example, the product may undergo photostability testing, shelf stability testing, agitation testing, pH testing, etc. These tests are often performed using molecule assessment equipment which conduct the test under a set of controlled conditions. However, if the molecule assessment equipment is not configured in a manner such that the samples under test are subjected to the conditions associated with the production process, the test results might not accurately reflect the stability of the biopharmaceutical product.BRIEF SUMMARY

[0003] Systems and methods described herein generally relate to modeling a production environment for a biopharmaceutical product to configure molecule assessment equipment in a manner that accurately reflects the production process. Generally, “molecule assessment’ refers to experiments conducted to compare and select therapeutic protein candidates, assess candidate fit to platform processes, and determine risks associated with manufacturability and stability. In some contexts, “molecule assessment” may also be referred to as ''developability.” To assess the candidate molecules, sensor data and / or configuration settings is obtained from the production environment and analyzed to determine the appropriate configuration of the molecule assessment equipment. In some embodiments, the sensor data and / or configuration settings is compared to a spatial model of the production environment to more precisely determine the environment conditions experienced by a biopharmaceutical product being produced within the production facility The systems and methods then analyze the sensor data and / or configuration settings to determine control values of the molecule assessment equipment that will approximate the same environmental conditions that the samples under test would experience in the production environment. As a result, the molecule assessment conducted using the molecule assessment equipment more accurately assesses the samples under test

[0004] In some aspects, the techniques described herein relate to a system for configuring molecule assessment equipment is provided. The system includes (I) molecule assessment equipment configured to conduct an automated test that assesses one or more characteristics of a sample under test, wherein the molecule assessment equipment includes a controller that controls an assessment environment in accordance with one or more control parameters; and (II) a computer comprising one or more processors that are configured to (1) obtain sensor data indicative of environmental conditions of a production environment at which the sample under test is to be produced; (2) convert the sensor data to control values of the one or more control parameters; and (3) perform at least one of (a) configuring the controller of the molecule assessment equipment using the control values, and (b) presenting the control values via an output device The molecule assessment equipment is then operated to execute the automated test of the sample under test after the controller is configured with the control values.

[0005] In some aspects, the techniques described herein relate to a method for configuring molecule assessment equipment configured to conduct an automated test that assesses one or more characteristics of a sample under test. The molecule assessment equipment includes a controller that controls an assessment environment in accordance with one or more control parameters. The method includes (1) obtaining, via one or more processors, sensor data indicative of environmental conditions of a production environment at which the sample under test is to be produced; (2) converting, via one or more processors, the sensor data to control values of the one or more control parameters; and (3) performing, via one or more processors, at least one of (a) configuring the controller of the molecule assessment equipment using the control values, and (b) presenting the control values via an output device; The molecule assessment equipment is then operated to execute the automated test of the sample under test after the controller is configured with the control values.

[0006] In some aspects, the techniques described herein relate to one or more non-transitory, computer-readable media storing instructions that, when executed by one or more processors, cause the one or more processors to (1) obtain sensor data indicative of environmental conditions of a production environment at which the sample under test is to be produced; (2) convert the sensor data to control values of the one or more control parameters; and (3) perform at least one of (a) configuring the controller of the molecule assessment equipment using the control values, and (b) presenting the control values via an output device; The molecule assessment equipment is then operated to execute the automated test of the sample under test after the controller is configured with the control valuesBRIEF DESCRIPTION OF THE DRAWINGS

[0007] The skilled artisan will understand that the figures described herein are included for purposes of illustration and are not limiting on the present disclosure. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the present disclosure. It is to be understood that, in some instances, various aspects of the described implementations may be shown exaggerated or enlarged to facilitate an understanding of the described implementations. In the drawings, like reference characters throughout the various drawings generally refer to functionally similar and / or structurally similar components.

[0008] FIG. 1 illustrates an example system in which the improved molecule assessment configuration may be determined.

[0009] FIG. 2 is an example production environment analyzed by the system of FIG. 1.

[0010] FIG. 3 illustrates a flow chart of an example method for configuring molecule assessment equipment.DETAILED DESCRIPTION

[0011] The various concepts introduced above and discussed in greater detail below may be implemented in any of numerous ways, and the described concepts are not limited to any particular manner of implementation. Examples of implementations are provided for illustrative purposes.

[0012] FIG. 1 illustrates an inspection system 100 according to an embodiment of the present disclosure. As illustrated, the system 100 includes molecule assessment equipment 120 via which a sample under test is subjected to test conditions to evaluate particular characteristics of the sample. The molecule assessment equipment 120 may be any type of molecule assessment equipment, for example, a photostability chamber, a thermostability chamber, an agitator, a viscosity tester, a pH analyzer, a protein concentration analyzer, and so on. In the biopharmaceutical context, the sample under test may be a proteintherapeutic, such as a monoclonal antibody and / or other types of protein therapeutics, a nucleic acid product, an antibody-drug conjugate, and / or other type of biopharmaceutical product.

[0013] As illustrated, the molecule assessment equipment 120 is communicatively coupled to a computer 140 via a network 110. The network 110 may be a single communication network, or may include multiple communication networks of one or more types (e.g , one or more wired and / or wireless local area networks (LANs), and / or one or more wired and / or wireless wide area networks (WANs) such as the Internet)

[0014] The molecule assessment equipment 120 is generally configured to subject a sample under test to a particular set of test conditions in order to perform an assessment. In some embodiments, the molecule assessment equipment 120 is configured to receive a single container that includes the sample under test In other embodiments, the molecule assessment equipment 120 is configured to receive a well plate that includes a plurality of samples under test. In these embodiments, the plurality of samples may include samples of different types in order to assess a plurality of candidate samples in parallel. It should be appreciated that while some molecule assessment equipment 120 may be able to automatically output an assessment of the sample under test, other molecule assessment equipment 120 require manual inspection of the samples under test after the molecule assessment equipment 120 has subjected the samples under test to the determined test conditions.

[0015] As seen in FIG.1 , the molecule assessment equipment 120 includes a processing unit 122, a network interface 124 and a memory 126. The processing unit 122 includes one or more processors, each of which may be a programmable microprocessor that executes software instructions stored in the memory 126 to execute some or all of the functions of the molecule assessment equipment 120 as described herein. Alternatively, one, some or all of the processors in the processing unit 122 may be other types of processors (e.g., application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), etc.), and the functionality of computer 104 as described herein may instead be implemented, in part or in whole, in hardware.

[0016] The network interface 124 may include any suitable hardware (e.g., front-end transmitter and receiver hardware), firmware, and / or software configured to communicate via network 1 10 using one or more communication protocols. For example, network interface 124 may be or include an Ethernet interface, enabling molecule assessment equipment 120 to communicate the computer 140 over the Internet or an intranet, etc.

[0017] The memory 126 may include one or more physical memory devices or units containing volatile and / or non-volatile memory. Any suitable memory type or types may be included, such as read-only memory (ROM), random access memory (RAM), flash memory, a solid-state drive (SSD), a hard disk drive (HDD), and so on. Collectively, memory 126 may store one or more software applications, data received / used by those applications, and data output / generated by those applications

[0018] The memory 126 may store the software instructions of a control module 132 that, when executed by processing unit 122, subjects a sample under test to test conditions defined by a control profile 134. The control profile 134 may associate the configurable control parameters associated with the molecule assessment equipment 120 with control values thereof. In some embodiments, the control values are static. For example, for a photostability test, the control profile 134 may define an illumination intensity value and illumination frequency and / or spectrum value(s) to configure an illumination unit that exposes the sample under test to the defined type of illumination, as well as a duration for said exposure. In other embodiments, the controlvalues may vary over time. For example, for an agitation test, the molecule assessment equipment 120 may subject the sample under test to different types of agitation to replicate different phases of the production process (e.g., production in the production environment, transport to a distribution center, etc.). In this example, the control profile 134 may include a sequence of agitation types and their corresponding timings and / or durations.

[0019] The sensor unit(s) 130 may be one or more sensors configured to sense various conditions associated with the production environment for the sample under test. For example, the sensor unit(s) 130 may be configured to generate illumination intensity data, temperate data, humidity data, and / or other data associated with environmental conditions of the production environment. In some embodiments, the sensor unit(s) 130 include illumination controllers that control the illumination emitted by a plurality of illuminators at the production environment. In these embodiments, the illumination sensor data may be the control setting for the various illuminators, as well as any illumination data recorded by photodetectors located in the production environment. In other embodiments, the sensor unit(s) 130 include an accelerometer unit that is associated with a sample container as the sample container moves through the production environment. In these embodiments, the motion data recorded by the accelerometer units may include accelerometer data that is recorded outside of the production environment (e.g., while the sample container is in transit to a distribution center).

[0020] In some embodiments, the sensor unit(s) 130 are in direct communication with the computer 140 via the network 110. in other embodiments, the sensor unit(s) 130 are instead configured to communicate with an intermediate device, such as a local hub or base station associated with the production environment. In these embodiments, the intermediate device relays the sensor data to the computer 140 via the network 110.

[0021] Similar to the molecule assessment equipment 120, the computer 140 includes a processing unit 142, a network interface 144 and a memory 146. The processing unit 142 includes one or more processors, each of which may be a programmable microprocessor that executes software instructions stored in the memory 146 to execute some or all of the functions of the computer 140, including the functions described with to the flowcharts described herein. Alternatively, one, some or all of the processors in the processing unit 142 may be other types of processors (e.g., application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), etc.), and the functionality of computer 140 as described herein may instead be implemented, in part or in whole, in hardware.

[0022] The network interface 144 may include any suitable hardware (e.g., front-end transmitter and receiver hardware), firmware, and / or software configured to communicate via network 1 10 using one or more communication protocols. For example, network interface 144 may be or include an Ethernet interface, enabling computer 140 to communicate with the molecule assessment equipment 120 and / or sensor unit(s) 130 over the Internet or an intranet, etc.

[0023] The output unit 148 may be any type of visual and / or audio output device (e.g , a computer monitor, touchscreen or other display, and / or a speaker, of computing 140, or a separate computing device having a display and / or speaker and coupled to computer 140, etc.)

[0024] The memory 146 may include one or more physical memory devices or units containing volatile and / or non-volatile memory. Any suitable memory type or types may be included, such as read-only memory (ROM), random access memory(RAM), flash memory, a solid-state drive (SSD), a hard disk drive (HDD), and so on. Collectively, memory 146 may store one or more software applications, data received / used by those applications, and data output / generated by those applications

[0025] The memory 146 may store the software instructions of a converter 147 that, when executed by processing unit 142, causes the computer 140 to analyze sensor data and / or configuration settings obtained from the sensor unit(s) 130 to define a control profile that approximates the conditions environmental conditions of the production environment. In embodiments where the molecule assessment equipment 120 is a photostability chamber, the converter 147 may analyze illumination data received from the sensor unit(s) 130 to generate a control profile to implement at the molecule assessment equipment 120.

[0026] In embodiments where the computer 140 only receives control settings for the illuminators at the production environment, the converted may analyze a spatial model 149 of the production environment that is stored in the memory 146. Based on the spatial model 149, the converter 147 may computationally derive an intensity of light at a position in the production environment associated with production of the sample. For example, the converter 147 may determine a distance from the position and the one or more illuminators and scale the control setting based on the distance to determine the control value to use in the control profile. For other values, such as illumination spectrum, the converter 147 may obtain directly from the sensor data and / or control settings.

[0027] In embodiments where the molecule assessment equipment 120 is an agitation tester, the converter 147 may generate a time profile that approximates the motion indicated by the received motion data. For example, the converter 147 may detect different motion patterns indicative of container motion during different stages of production. Accordingly, the converter 147 may parameterize the motion data for the motion patterns into control parameters associated with the molecule assessment equipment 120 such that the container is subjected to similar motion patterns. The converter 147 may then define a duration, a number of loops, and / or a sequence of motion patterns to define a control profile to be implemented at the agitation tester.

[0028] In some embodiments, the sample container for high throughput assessment (e.g., a well of a well plate, also referenced herein as an “assessment container”) may vary from an individual container the sample will be located in during production (a “production container”) Based on experimental testing, it has been determined that using a 384 well plate that having 30 or 50 microliter wells or a 96 well plate having 300 microliter wells that are sealed, e.g., using autoseal or similar types of foil sealing techniques as the assessment container significantly prevent liquid samples from evaporating when conducting long-term molecule assessments (e.g., assessments that last multiple weeks, such as 2 weeks, 4 weeks, 8 weeks, 12 weeks, and / or assessments performed at a temperature above room temperature, such as 40° Cand so on). For other types of molecule assessments (such as photostability and / or agitation assessments), the well plate may be sealed manually using a film seal (e.g., MSC-1001 BioRad Film).

[0029] Additionally, it has be determined that a higher fill volume also reduces evaporation. That is, the higher the fill volume, the lower the amount of evaporation. That said, the benefits of lower evaporation should be assessed relative to the additional amount of sample required to perform the assessment. Based on experimental testing, we found that a fill volume between 150 microliters to 200 microliters balances these considerations. Using well plates described above helps to enable execution of molecule assessment of a large number of samples (e.g., therapeutic protein candidates) with less materials and resources.

[0030] In one comparative thermostability experiment using a 200 microliter 96 well plate and a fill volume of 150 microliters, the autoseal foil sealing technique only experienced a 4.5% change in weight after 4 weeks at 40° C, as compared to 23% and 9.4% when using film seals (MSC-1001 BioRad Film and MSB-1001 BioRad Film).

[0031] While using a well plate that has 96 or 384 wells enables a large number of samples under test can be assessed simultaneously by the molecule assessment equipment, the samples are not typically produced and distributed in well plates. Accordingly, in some embodiments, the converter 147 may analyze the properties of the assessment and production containers to adjust the control values included in the control profile. As one example, the converter 147 may determine a container material, thickness, transparency, and / or well density to determine a difference in light permeability between the assessment and production containers. The converter 147 may then scale or otherwise adjust the control values included in the control profile based upon the difference. In some embodiments, the adjustment may be derived by comparing experimental data generated by executing the same control profile when different container types are received into the molecule assessment equipment 120.

[0032] The computer 140 may then configure the molecule assessment equipment 120 with the control profile generated by the converter 147 to function as the control profile 134. In some embodiments, the computer 140 directly configures the molecule assessment equipment 120 by transmitting the control profile via the network 110. In other embodiments, the computer 140 presents the control values and / or instructions for configuring the molecule assessment equipment 120 with the same via the output unit 148. As a result, a molecule assessment technician is able to manually configure the molecule assessment equipment 120 in a manner that produces the determined test conditions.

[0033] It should be appreciated that while FIG 1 only depicts a single molecule assessment equipment 120, in other embodiments, the computer 140 may analyze the sensor data to generate multiple control profile that respectively implement the environmental conditions of the production environment via respective control parameters of any number of molecule assessment equipment.

[0034] FIG. 2 is an example production environment 200 associated with environmental conditions that are analyzed by a computer (such as the computer 140) to configure a control profile of molecule assessment equipment (such as the molecule assessment equipment 120). The example production environment 200 includes workstations 254 at which the sample under test may be produced (if selected after the molecule assessment stage).

[0035] The production environment 200 includes a sensor unit 230 (such as a sensor unit 130) configured to sense environmental conditions associated with the production environment 200. For example, the sensor unit 230 may be configured to sense temperature, humidity, and / or other environmental conditions that can affect the stability of biopharmaceutical products. The sensor unit 230 may report the generated sensor data directly to the computer or via a local hub device located at the production environment 200 that is communicatively coupled to multiple sensor units 230.

[0036] The example production environment 200 also includes an illumination controller 250 (which may be a sensor unit 130) operative coupled to illuminators 252. The illumination controller 250 may be configured to set an illumination intensity of the illuminators 252. Additionally, the illumination controller 250 may be configured to set a frequency (or spectrum of frequencies) of light emitted by the illuminators 252. In some embodiments, the illumination controller 250 is coupled to one or more photodetectors (not depicted) disposed proximate to the workstations 254 to implement closed loop control of the illuminators252 or otherwise detect the actual amount of illumination experienced by objects at the workstations 254. The illumination controller 250 may be configured to report the control settings for the illuminators 252 to a computer (such as the computer 140).

[0037] FIG. 3 is a flow diagram of an example method 300 for configuring molecule assessment equipment (such as the molecule assessment equipment 120). The method 300 may be performed by one or more processors (such as the processing unit 142) of a computer (such as the computer 140).

[0038] The molecule assessment equipment is configured to conduct an automated test that assesses one or more characteristics of a sample under test In some embodiments, the sample under test is a protein therapeutic, a nucleic acid, or an antibody-drug conjugate. In embodiments in which the sample under test is a protein therapeutic, the protein therapeutic may be a monoclocal antibody. The molecule assessment equipment may be photostability test equipment, thermostability test equipment, agitation test equipment, or another type of test equipment used during molecule assessment. The molecule assessment equipment includes a controller (such as the control module 132) that controls an assessment environment in accordance with one or more control parameters

[0039] In some embodiments, the sample under test is a first sample under test of a plurality of samples under test housed in respective wells of a well plate. In some embodiments, the well plate includes 384 wells that hold a liquid volume of between about 30 to about 70 microliters or the well plate includes 96 wells that hold a liquid volume of about 300 microliters. In some embodiments, the samples under test are filled into the wells using a fill volume of 150 microliters and the well plate is sealed using auto seal foil. In these embodiments, the well of the well plate may be the assessment container and the molecule assessment equipment may be configured to receive the well plate and conduct the automated test to assess the one or more characteristics of the plurality of samples under test.

[0040] The method 300 begins at block 302 when the computer obtains sensor data indicative of environmental conditions of a production environment (such as the production environment 200) at which the sample under test is to be produced. In some embodiments, the computer obtains the sensor data from an illumination controller (such as the illumination controller 250) configured to control illumination settings at the production environment. In these embodiments, the sensor data may be data generated by a photodetector coupled to the illumination controller 250 or a control setting implemented by the illumination controller. In these embodiments, the environmental conditions of the production environment may include one or more conditions from the group including illumination intensity, illumination frequency or spectrum, distance from illumination source, production duration, and temperature.

[0041] In embodiments where the molecule assessment equipment is an agitator, the sensor data may be generated by an accelerometer associated with a sample container as a sample container is moved through the production environment and to a point of distribution. In the embodiments, the environmental conditions of the production environment may include an amount of agitation experienced by the sample container as the sample container is moved through the production environment and to the point of distribution.

[0042] At block 304, the computer converts the sensor data to control values of the one or more control parameters. In embodiments where the molecule assessment equipment is a photostability tester, the computer may be configured to determine an amount of light the sample under test is exposed to during a production process performed in the production environment andset the control values such that the sample under test is exposed to the amount of light during the automated test. Accordingly, the control parameters may include a light intensity and a duration of exposure to the light. In embodiments where the sensor data is a control setting of an illuminator, the computer may compare the sensor data to a spatial model of the production environment (such as the spatial model 149) to determine the environmental conditions at a position within the production environment associated with production of the sample under test. For example, the computer may scale an illumination intensity based on a distance between the position and the nearest illuminator(s).

[0043] As another example, the computer may be configured to determine a difference in a physical characteristic of the sample under test when housed in an assessment container when assessed by the molecule assessment equipment and the sample under test when housed in a production container as the sample container is moved through the production environment and to the point of distribution. For example, the computer may determine a difference in container material, thickness, transparency, type (e g., individual vial vs well plate). Based on the difference, the computer may adjust the control values.

[0044] At block 306, the computer performs at least one of (i) configuring the controller of the molecule assessment equipment using the control values, and (ii) presenting the control values via an output device (such as the output unit 148). In embodiments where the control values are presented via the output device, an operator may manually configure the controller of the molecule assessment equipment with the control values. Regardless, after the molecule assessment equipment is configured with the control values, the molecule assessment equipment is operated to execute the automated test of the sample under test

[0045] Additional considerations pertaining to this disclosure will now be addressed.

[0046] Some of the figures described herein illustrate example block diagrams having one or more functional components. It will be understood that such block diagrams are for illustrative purposes and the devices described and shown may have additional, fewer, or alternate components than those illustrated. Additionally, in various embodiments, the components (as well as the functionality provided by the respective components) may be associated with or otherwise integrated as part of any suitable components.

[0047] Embodiments of the disclosure relate to a non-transitory computer-readable storage medium having computer code thereon for performing various computer-implemented operations. The term “computer-readable storage medium” is used herein to include any medium that is capable of storing or encoding a sequence of instructions or computer codes for performing the operations, methodologies, and techniques described herein. The media and computer code may be those specially designed and constructed for the purposes of the embodiments of the disclosure, or they may be of the kind well known and available to those having skill in the computer software arts. Examples of computer-readable storage media include, but are not limited to: magnetic media such as hard disks, floppy disks, and magnetic tape; optical media such as CD-ROMs and holographic devices; magneto-optical media such as optical disks; and hardware devices that are specially configured to store and execute program code, such as ASICs, programmable logic devices (“PLDs”), and ROM and RAM devices.

[0048] Examples of computer code include machine code, such as produced by a compiler, and files containing higher-level code that are executed by a computer using an interpreter or a compiler. For example, an embodiment of the disclosure may be implemented using Java, C++, or other object-oriented programming language and development tools. Additional examples ofcomputer code include encrypted code and compressed code. Moreover, an embodiment of the disclosure may be downloaded as a computer program product, which may be transferred from a remote computer (e. g. , a server computer) to a requesting computer (e.g., a client computer or a different server computer) via a transmission channel. Another embodiment of the disclosure may be implemented in hardwired circuitry in place of, or in combination with, machine-executable software instructions.

[0049] As used herein, the singular terms “a,” “an,” and “the” may include plural referents, unless the context clearly dictates otherwise.

[0050] As used herein, the terms “approximately,” “substantially,” “substantial” and “about’ are used to describe and account for small variations. When used in conjunction with an event or circumstance, the terms can refer to instances in which the event or circumstance occurs precisely as well as instances in which the event or circumstance occurs to a close approximation. For example, when used in conjunction with a numerical value, the terms can refer to a range of variation less than or equal to ±10% of that numerical value, such as less than or equal to ±5%, less than or equal to ±4%, less than or equal to ±3%, less than or equal to ±2%, less than or equal to ±1%, less than or equal to ±0 5%, less than or equal to ±0 1%, or less than or equal to ±005%. For example, two numerical values can be deemed to be “substantially” the same if a difference between the values is less than or equal to ±10% of an average of the values, such as less than or equal to ±5%, less than or equal to ±4%, less than or equal to ±3%, less than or equal to ±2%, less than or equal to ±1%, less than or equal to ±0.5%, less than or equal to ±0.1%, or less than or equal to ±0.05%.

[0051] Additionally, amounts, ratios, and other numerical values are sometimes presented herein in a range format. It is to be understood that such range format is used for convenience and brevity and should be understood flexibly to include numerical values explicitly specified as limits of a range, but also to include all individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly specified.

[0052] While the present disclosure has been described and illustrated with reference to specific embodiments thereof, these descriptions and illustrations do not limit the present disclosure. It should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the present disclosure as defined by the appended claims. The illustrations are not necessarily drawn to scale. There may be distinctions between the artistic renditions in the present disclosure and the actual apparatus due to manufacturing processes, tolerances and / or other reasons. There may be other embodiments of the present disclosure which are not specifically illustrated. The specification (other than the claims) and drawings are to be regarded as illustrative rather than restrictive. Modifications may be made to adapt a particular situation, material, composition of matter, technique, or process to the objective, spirit and scope of the present disclosure All such modifications are intended to be within the scope of the claims appended hereto. While the techniques disclosed herein have been described with reference to particular operations performed in a particular order, it will be understood that these operations may be combined, sub-divided, or re-ordered to form an equivalent technique without departing from the teachings of the present disclosure Accordingly, unless specifically indicated herein, the order and grouping of the operations are not limitations of the present disclosure.

Claims

WHAT IS CLAIMED:

1. A system for configuring molecule assessment equipment, comprising: molecule assessment equipment configured to conduct an automated test that assesses one or more characteristics of a sample under test, wherein the molecule assessment equipment includes a controller that controls an assessment environment in accordance with one or more control parameters; a computer comprising one or more processors that are configured to: obtain sensor data indicative of environmental conditions of a production environment at which the sample under test is to be produced; convert the sensor data to control values of the one or more control parameters; and perform at least one of: configuring the controller of the molecule assessment equipment using the control values, and presenting the control values via an output device; wherein the molecule assessment equipment is operated to execute the automated test of the sample under test after the controller is configured with the control values.2 The system of claim 1, wherein: the sample under test is a first sample under test of a plurality of samples under test housed in respective wells of a well plate; the molecule assessment equipment is configured to: receive the well plate; and conduct the automated test to assess the one or more characteristics of the plurality of samples under test.

3. The system of claims 1 or 2, wherein the molecule assessment equipment is photostability test equipment.

4. The system of claim 3, wherein the environmental conditions of the production environment include one or more conditions from the group including: illumination intensity, illumination frequency or spectrum, distance from illumination source, production duration, and temperature.

5. The system of claim 4, wherein to convert the sensor data to control values, the processors are configured to: determine an amount of light the sample under test is exposed to during a production process performed in the production environment; and set the control values such that the sample under test is exposed to the amount of light during the automated test.

6. The system of claim 5, wherein the one or more control parameters include a light intensity and a duration of exposure.

7. The system of any one of claims 1 to 6, wherein the sensor data is obtained from an illumination controller configured to control illumination settings at the production environment.

8. The system of any one of claims 7, wherein the sensor data is compared to a spatial model of the production environment to determine the environmental conditions at a position within the production environment associated with production of the sample under test.

9. The system of claim 1 or 2, wherein the molecule assessment equipment is an agitator10 The system of claim 9, wherein the environmental conditions of the production environment include an amount of agitation experienced by a sample container as the sample container is moved through the production environment and to a point of distribution.11 The system of claim 10, wherein the sensor data is generated by an accelerometer associated with a sample container as the sample container is moved through the production environment and to the point of distribution.12 The system of any one of claims 1 to 11 , wherein the one or more processors are configured to: determine a difference in a physical characteristic of the sample under test when housed in an assessment container when assessed by the molecule assessment equipment and the sample under test when housed in a production container as the sample container is moved through the production environment and to the point of distribution; and adjust the control values based on the difference.13 The system of any one of claims 1 to 12, wherein the assessment container is a well of a well plate14 The system of claim 13, wherein the well plate includes 384 wells that hold a liquid volume of between about 30 to about 70 microliters or the well plate includes 96 wells that hold a liquid volume of about 300 microliters15 The system of claim 14, wherein the sample under test has a fill volume of 150 microliters.16 The system of any one of claims 13 to 15, wherein the well plate is sealed using autoseal foil.17 The system of any one of claims 1 to 16, wherein the sample under test comprises a protein therapeutic, a nucleic acid, or an antibody-drug conjugate.18 The system of claim 13, wherein the protein therapeutic is a monoclonal antibody.19 A method for configuring molecule assessment equipment configured to conduct an automated test that assesses one or more characteristics of a sample under test, wherein the molecule assessment equipment includes a controller that controls an assessment environment in accordance with one or more control parameters; the method comprising: obtaining, via one or more processors, sensor data indicative of environmental conditions of a production environment at which the sample under test is to be produced; converting, via one or more processors, the sensor data to control values of the one or more control parameters; and performing, via one or more processors, at least one of: configuring the controller of the molecule assessment equipment using the control values, and presenting the control values via an output device; wherein the molecule assessment equipment is operated to execute the automated test of the sample under test after the controller is configured with the control values.20 The method of claim 19, wherein: the sample under test is a first sample under test of a plurality of samples under test housed in respective wells of a well plate and the molecule assessment equipment is configured to (i) receive the well plate; and (II) conduct the automated test to assess the one or more characteristics of the plurality of samples under test.21 The method of claims 19 or 20, wherein the molecule assessment equipment is photostability test equipment.22 The method of claim 21 , wherein the environmental conditions of the production environment include one or more conditions from the group including: illumination intensity, illumination frequency or spectrum, distance from illumination source, production duration, and temperature.23 The method of claim 22, wherein converting the sensor data to control values comprises: determining, via one or more processors, an amount of light the sample under test is exposed to during a production process performed in the production environment; and setting, via the one or more processors, the control values such that the sample under test is exposed to the amount of light during the automated test.24 The method of claim 23, wherein the one or more control parameters include a light intensity and a duration of exposure.25 The method of any one of claims 19 to 24, wherein the sensor data is obtained from an illumination controller configured to control illumination settings at the production environment.27 The method of claim 19 or 20, wherein the molecule assessment equipment is an agitator.28 The method of claim 27, wherein the environmental conditions of the production environment include an amount of agitation experienced by a sample container as the sample container is moved through the production environment and to a point of distribution.29 The method of claim 28, wherein the sensor data is generated by an accelerometer associated with a sample container as the sample container is moved through the production environment and to the point of distribution.30 The method of any one of claims 19 to 29, further comprising: determining, via the one or more processors, a difference in a physical characteristic of the sample under test when housed in an assessment container when assessed by the molecule assessment equipment and the sample under test when housed in a production container as the sample container is moved through the production environment and to the point of distribution; and adjusting, via the one or more processors, the control values based on the difference.31 The method of any one of claims 19 to 30, wherein the assessment container is a well of a well plate.32 The method of claim 31, wherein the well plate includes 384 wells that hold a liquid volume of between about30 to about 70 microliters or the well plate includes 96 wells that hold a liquid volume of about 300 microliters.33 The method of claim 32, wherein the sample under test has a fill volume of 150 microliters.34 The method of any one of claims 31 to 33, wherein the well plate is sealed using autoseal foil.35 The method of any one of claims 19 to 34, wherein the sample under test comprises a protein therapeutic, a nucleic acid, or an antibody-drug conjugate36 The method of claim 35, wherein the protein therapeutic is a monoclonal antibody.37 One or more non-transitory, computer-readable media storing instructions that, when executed by one or more processors, cause the one or more processors to perform the method of any one of claims 19 to 36.

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