A container for protecting light sensitive contents and processes thereof

Abstract

The present disclosure relates to a bioprocess container 100 for protecting an enclosed content from one or more radiations in a surrounding and method thereof. The bioprocess container (100) includes an enclosure (600) constructed from a plurality of layers (110). The enclosure (600) is provided with at least one port (108) configured to facilitate the introduction or removal of the enclosed content. The plurality of layers (110) includes an outer layer (106) adapted to provide structural support and one or more middle layers (104) positioned between the outer layer (106) and an inner layer (102). The middle layers (104) are designed to block the penetration of one or more radiations from the external environment into the inner layer (102). The inner layer (102) is fabricated from a material that is biologically and / or chemically compatible with the enclosed content.

Description

A CONTAINER FOR PROTECTING LIGHT SENSITIVE CONTENTSAND PROCESSES THEREOFTECHNICAL FIELD

[0001] The present disclosure relates to the field of equipment, specifically containers, used in processes, such as bioprocesses. More particularly, the present disclosure pertains to a flexible bioprocess container (hereinafter ‘container’ or ‘flexible container’ used interchangeably) capable of blocking one or more molecules and one or more radiations to protect the enclosed content and method thereof.BACKGROUND

[0002] Bioprocess engineering is used to manufacture a variety of products ranging, e.g. pharmaceuticals, food products, cell & gene therapy products etc. In such processes, it is desirable to maximize the yield and quality of the target product to maximize efficiency. Some bio-processes have been shown to be negatively impacted by exposure to light, which results in decreased yield. Publication "Media photo-degradation in pharmaceutical biotechnology-impact of ambient light on media quality, cell physiology, and IgG production in CHO cultures”, J Chem Technol Biotechnol. 2018 Aug; 93(8):2141-2151, demonstrated drastically decreased IgG titers (up to -80%) and specific growth rates (-50% to -90%) as a result of media exposure to light. Thus, it is desirable to protect the bioprocess from wavelengths of light that negatively affect production.

[0003] Single-use systems are very common in bioprocess engineering, where the apparatus used for the bioprocess is discarded after one use. Single-use systems offer numerous advantages such as lower manual labour, quicker set-up time, reduced chance of contamination, greater flexibility etc. Thus, it is desirable to provide the above-mentioned protection in single-use systems e.g. bags, pipes etc.

[0004] Bioprocesses need to be done in a very clean and controlled environment, and the materials used should not adversely affect the quality or quantity of the yield. Thus, it is desirable that the solution for light protection should not introduce any materials in contact with the bioprocess that could negatively affect the yield or quality e.g. leachable, extractable, endotoxins etc.

[0005] During the bioprocess, it is critical to take routine samples of the product to ensure quality is being maintained. For steps that are sensitive to light, it may be required that the sample collection and transport be done in a manner that protects it from light, so as to notimpact the measurements being done. Thus, it is desirable that the solution for light protection also accounts for sampling and sample transport.

[0006] Typically, transparent glass and / or transparent plastic containers are used in bioprocesses. Such containers fail to protect the contents from undesirable wavelengths of light.

[0007] One approach to address this problem is the use of special bulbs or special fdters around light fixtures to cut off undesirable wavelengths. However, these arrangements are costly and time-consuming to install, as they require modification of the facility infrastructure.

[0008] Another approach is to use non-transparent glass bottles (e.g, amber bottles). This has been used tor final drug packaging and is typically for small amounts. This approach is not suitable for industrial -scale bioprocess engineering, where 500+- litre containers are routinely required. It is impractical to make, transport, store, or use such large glass bottles.

[0009] A prior art reference ‘US 10,801,003 B2’, titled ‘Single use bioreactor’, discloses a single-use bioreactor that may be placed in an outer shell to provide light protection. As can be understood, providing the outer shell for the container shall require the use of an additional component, which can be bulky, have size limitations, and require additional logistics and handling overhead in the process. Additionally, sterilization of such an outer container may be problematic if it is a reusable component.

[0010] There is, therefore, a dire need in the art for a simple, easy-to-use, costefficient, sterilizable, bioprocess compatible, flexible container that blocks radiations or light, which can otherwise degrade the yield and / or quality of bioprocesses and requires minimal changes on behalf of users for incorporation into existing processes.OBJECTS OF THE PRESENT INVENTION

[0011] Some of the objects of the present disclosure, which at least one embodiment herein satisfies are as listed herein below.

[0012] A general object of the present disclosure is to provide a simple, easy-to-use, and cost-effective solution to prevent the degradation of yield or quality for processes that may be sensitive to light (UV or visible), while retaining all the benefits of single-use systems.

[0013] An object of the present disclosure is to provide a solution to the problem of degradation of the enclosed content or quality for processes due to light exposure that does not require any additional parts / equipment.

[0014] An object of the present disclosure is to provide a solution to the problem of degradation of the enclosed content or quality for processes due to light exposure that is not bulky.

[0015] An object of the present disclosure is to provide a container that provides the desired yield by protecting contents from various types of radiation that may negatively impact the outcome.

[0016] Another object of the present disclosure is to provide a container made of flexible materials that create containers of various shapes and sizes to meet the needs of different processes while simplifying logistics related to transport, storage, and disposal.

[0017] Another object of the present disclosure is to provide a sterilizable container for use in sensitive applications like food and drug manufacturing, where sterilization may be conducted via Gamma irradiation, ethylene oxide treatment, or other such techniques.

[0018] Another object of the present disclosure is to provide a container that is compatible with lab and industrial-scale bioprocess manufacturing techniques, such as those used for food and drug production. Such techniques would encompass areas such as cell and gene therapy production as well, which utilize equipment and methodologies found in bioprocess-based manufacturing but may not be bioprocess-based.

[0019] Another object of the present disclosure is to provide a container that does not contaminate or react with the internal light-sensitive contents.

[0020] Another object of the present disclosure is to provide a container that protects the light-sensitive contents from contamination or reaction with external contents, such as endotoxins, bacteria, oxygen, and the like.

[0021] These and other objects of the present invention will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.SUMMARY

[0022] Within the scope of this application, it is expressly envisaged that the various aspects, embodiments, examples, and alternatives set out in the preceding paragraphs, in the claims and / or in the following description and drawings, and in particular the individual features thereof, may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments unless such features are incompatible.

[0023] The present disclosure relates to the field of equipment, specifically containers, used in processes, such as bioprocesses. More particularly, the present disclosure pertains to a flexible container that blocks wavelengths of radiation to protect enclosed contents and a method thereof.

[0024] In an aspect, the proposed bioprocess container to protect an enclosed content includes an inner layer defining a hollow enclosure for the input; an outer layer enclosing the inner layer to protect the container from the external environment; and one or more middle layers configured between the outer layer and the inner layer. In an aspect, one or more middle layers are configured to block a range of wavelengths of radiation such as light and ultra-violet rays to prevent degradation of the contents held within the hollow enclosure or the reactions that may occur.

[0025] In another aspect, the container may include one or more ports for communication with the hollow enclosure. In a preferred embodiment, there will be at least one port configured with a fitting forming inlet passages for the input, or fitting forming harvest ports for extraction.

[0026] In yet another aspect, the outer layer, the inner layer, and one or more middle layers of the container may be made of flexible materials to enable a change in shape or size of the container to a plurality of bag-like shapes required for different processes. Such shapes may be 2D or 3D bags, tank liners, powder bags, sampling bags, and the like, and may range from a milliliter to thousands of liters in size.

[0027] Various objects, features, aspects, and advantages of the present disclosure will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like features.BRIEF DESCRIPTION OF DRAWINGS

[0028] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0029] FIG. 1 illustrates a block diagram of a bioprocess container to protect an enclosed content from one or more radiations in a surrounding, in accordance with an embodiment of the present invention.

[0030] FIG. 2 illustrates a method of protecting an enclosed content from one or more radiations in a surrounding using a bioprocess container, in accordance with an embodiment of the present invention.

[0031] FIG. 3 illustrates an exemplary view of the proposed bioprocess container to protect an enclosed content from one or more radiations in a surrounding, in accordance with an embodiment of the present invention.

[0032] FIG. 4 illustrates an exemplary graphical representation showing the results of the absorption spectrum for fdm without one or more middle layers used for conventional containers (a), and the absorption spectrum for the fdm with one or more middle layers used in the proposed bioprocess container (b), in accordance with an embodiment of the present invention.

[0033] FIG. 5 illustrates an exemplary representation of one or more windows (a) and the exemplary implementation of one or more patches (b) in the bioprocessor container, in accordance with an embodiment of the present invention.DETAIL DESCRIPTION OF THE PRESENT INVENTION

[0034] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0035] Accordingly, while exemplary embodiments of the invention are capable of various modifications and alternative forms, embodiments thereof are shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit example embodiments of the present invention to the particular forms disclosed. On the contrary, example embodiments are to cover all modifications, equivalents, and alternatives falling within the scope of the invention. Like numbers refer to like elements throughout the description of the figures.

[0036] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limited of example embodiments of the invention. As used herein, the singular forms "a," "an," and "the," are intended to include the plural forms as well, unless the context clearly indicates otherwise. As used herein, the terms"and / or" and "at least one of include any and all combinations of one or more of the associated listed items. It will be further understood that the terms “comprises,” “comprising,” “includes,” and / or “including,” when used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0037] It should also be noted that in some alternative implementations, the functions / acts noted may occur out of the order noted in the figures. For example, two figures shown in succession may in fact be executed substantially concurrently or may sometimes be executed in the reverse order, depending upon the functionality / acts involved.

[0038] Reference numerals used:600- Enclosure / Hollow enclosure100- Bioprocess container102- Inner layer104- One or more middle layers106- Outer layer108- At least one port / Inlet port110- Plurality of layers112- One or more non-opaque windows / One or more windows114- One or more sensors116- One or more attachments

[0039] Hereinafter, exemplary embodiments of the present disclosure will be described with reference to the accompanying drawings. The various embodiments will be explained in more detail with reference to FIGS. 1-5.

[0040] The embodiments described herein relate to a flexible container that blocks wavelengths of radiations such as light to protect enclosed contents and processes thereof. The flexible container includes an inner layer, an outer layer, and one or more middle layers configured between the outer layer and the inner layer. One or more middle layers are configured to block a range of wavelengths of light and ultra-violet rays to prevent degradation of the biomass held in the container. The container further includes one or more input ports each configured with a fitting forming inlet passages for the biomass, and one or more output ports each configured with a fitting forming harvest ports for the biomass. The inner layer is liquid impermeable and biocompatible, one or more middle layers absorb andblock the undesirable range of wavelength of light, and the outer layer protects the container from the external environment. All layers are made of flexible materials.

[0041] FIG. 1 illustrates a bioprocess container 100 to protect an enclosed content from one or more radiations in a surrounding, in accordance with an embodiment of the present invention.

[0042] The present disclosure relates to a bioprocess container 100 designed to protect an enclosed content from exposure to one or more radiations present in a surrounding environment. The bioprocess container 100 comprises an enclosure 600 constructed from a plurality of layers 110. The enclosure 600 is provided with at least one port (108) to receive content for enclosing in the enclosure 600 or to exit the enclosed content from the enclosure 600.

[0043] In an embodiment, the enclosure 600 is provided with at least one inlet port 108 configured to facilitate the introduction of content into the interior of the Enclosure 600 and at least one outlet port 112 designed to allow the removal of the enclosed content from the enclosure 600.

[0044] The plurality of layers 110 constituting the enclosure 600 includes one or more middle layers 104 positioned between an outer layer 106 and an inner layer 102. The inner layer 102 is configured to accommodate the enclosed content. The outer layer 106 is constructed from a material to provide puncture resistance and / or structural support and to prevent the ingress of external molecules into the enclosure 600. At least one of the middle layers 104 is designed to block the penetration of one or more radiations from the external environment into the inner layer 102. The inner layer 102 is fabricated from a liquid impermeable material to prevent the leakage of the enclosed content into any of the layers constituting the enclosure 600 and provides chemical and / or biological compatibility with the enclosed contents.

[0045] In another embodiment, the enclosure 600 is having at least one port to receive content for enclosing in the enclosure 600, and to exit the enclosed content from the enclosure.

[0046] In an embodiment, at least one of the plurality of layers 110 is adapted to prevent the exchange of one or more molecules between the enclosure 600 and the external environment.

[0047] In an embodiment, at least one of the plurality of layers 110 may incorporate one or more sensors 114 capable of detecting parameters associated with the enclosed content.

[0048] In these embodiments, one or more sensors 114 may facilitate giving a direct visual indication (for. eg. colour change).

[0049] In another embodiment, the sensors 114 may configured to transmit the sensed parameters to a remotely located device and display the acquired data on a display interface of the connected device 116.

[0050] In another embodiment, the bioprocess container 100 includes one or more windows 116 secured on one or more middle layers 104, adapted to facilitate a visual inspection and / or an optical analysis of the enclosed content.

[0051] In these embodiments, one or more patches 116-1 are attached to the outer side of one or more windows 116. The patches 116-1 may be securely removable for the visual inspection and / or optical analysis of the enclosed content.

[0052] In another embodiment, the bioprocess container (100) further includes one or more attachments (114) for processing and / or monitoring the enclosed contents.

[0053] In these embodiments, one or more attachments (114) are selected from any or a combination of ports, tubes, spargers, impellers, sensors, or fdters.

[0054] In these embodiments, the outer layer 106 is adapted to provide structural support. The outer layer 106 is a puncture resistance layer having weight-carrying capacity and other mechanical properties to store the enclosed content.

[0055] In these embodiments, one or more radiations are selected from any or a combination of ultraviolet (UV) radiation, visible light, infrared (IR) radiation, X-rays, gamma rays, or microwaves.

[0056] In these embodiments, one or more molecules are selected from any or a combination of oxygen, carbon dioxide, water vapor, particulate matter, contaminants, microorganisms, endotoxins, particles, and one or more gases.

[0057] In these embodiments, the inner layer is a liquid impermeable, wherein the inner layer is made of a chemically compatible and / or biocompatible material selected from any, or combination of low-density polyethylene (LDPE), ultra-low-density polyethylene (ULDPE), high-density polyethylene (HDPE), low-density polyethylene (LDP), Polyolefins, Fluoropolymers including Teflon (PTFE) and fluorinated ethylene propylene (FEP), or Thermoplastic elastomers (TPEs), Ethylene Vinyl Acetate copolymer, Teflon, or polypropylene.

[0058] In these embodiments, one or more middle layers are made of a material selected from any or a combination of film with black masterbatch, film with yellow masterbatch, film with coloured masterbatch, polyolefins, ultra-violet (UV) absorbers, metalfoils, metal coatings, ceramic coatings, carbon-based material, nanocomposites, or photonic crystals.

[0059] In these embodiments, the outer layer the outer layer is made of a structurally strong material selected from any, or a combination of High-density polyethylene (HDPE), Polypropylene (PP), Polyvinyl chloride (PVC), Acrylonitrile Butadiene Styrene (ABS), or Polyethylene Terephthalate (PET), metal sheet, glass or composite material.

[0060] In an embodiment, one or more sensors 114 may include but are not limited to, Light Sensors, Radiation Sensors, a pH sensor, a temperature sensor, or an oxygen sensor.

[0061] In another embodiment, one or more middle layers (104) are co-extruded and / or laminated to each other to form a single middle layer.

[0062] In another embodiment, one or more middle layers (104) are co-extruded and / or laminated to the outer layer (106) to form one single outer layer (106);

[0063] In another embodiment, one or more middle layers (104) are co-extruded and / or laminated to the inner layer (106) to form one single inner layer (106);

[0064] In another embodiment, the inner layer (102), the outer layer (106), and one or more middle layers (104) are co-extruded and / or laminated to each other to form a single layer.

[0065] In these embodiments, the container is a single-use container with a shape selected from any or a combination of tank liner, powder bag, sampling bag, mixer bag, bioreactor, flat bag, pipe, or any other shape based on the light-sensitive content being held in the container.

[0066] In these embodiments, the bioprocess container 100 may be pre-sterilized using gamma irradiation, x-ray irradiation, e-beam irradiation, ETO, or other sterilization methods.

[0067] In these embodiments, the bioprocess container 100 may be sterilized using irradiation techniques, autoclave, or other sterilization methods used by the user.

[0068] In these embodiments, the bioprocess container 100 may be sterile or non- sterile.

[0069] FIG. 2 illustrates a method 200 of protecting an enclosed content from one or more radiations in a surrounding using a bioprocess container 100, in accordance with an embodiment of the present invention.

[0070] The method 200 can be summarized in the following steps, as shown in FIG. 2:

[0071] The present disclosure relates to the method 200 for protecting content from one or more radiations in a surrounding using a bioprocess container (100).

[0072] At block 202, method 200 comprises providing an enclosure 600 having a plurality of layers 110. The enclosure comprises at least one port 108 to receive the content for enclosing in the enclosure 600 or to exit the enclosed content from the enclosure 600.

[0073] At block 204, the method 200 further comprises sandwiching one or more middle layers 104 of the plurality of layers 110 between an outer layer 106 and an inner layer 102 of the plurality of layers 110 such that the inner layer 102 receives the content for enclosing.

[0074] At block 206, the outer layer 106 is a puncture resistance layer adapted to provide structural support for the enclosed content inside enclosure 600.

[0075] At block 208, at least one layer of one or more middle layers 104 is adapted to prohibit entry (210) of one or more radiations from the surrounding in the inner layer 102.

[0076] At block 210, the inner layer is an impermeable layer and provides biological and / or chemical compatibility with the enclosed content.

[0077] In these embodiments, one or more sensors 114 are disposed on an exterior surface 106-1 of the outer layer 106 to sense one or more content parameters.

[0078] In these embodiments, the bioprocess container 100 includes one or more windows 116 secured on one or more middle layers 104, adapted to facilitate a visual inspection and / or an optical analysis of the enclosed content.

[0079] In these embodiments, one or more patches 116-1 are attached to an outer side of one or more windows 116 to securely removable for the visual inspection and / or optical analysis of the enclosed content.

[0080] In these embodiments, the bioprocess container 100 may have additional attachments as per the needs of the end user, some examples of which are extra ports, tubing, spargers, impellers, and the like.

[0081] In these embodiments, one or more radiations are selected from any or a combination of ultraviolet (UV) radiation, visible light, infrared (IR) radiation, X-rays, gamma rays, or microwaves.

[0082] In these embodiments one or more molecules are selected from any, or a combination of oxygen, carbon dioxide, water vapor, particulate matter, contaminants, microorganisms, endotoxins, or particles

[0083] In these embodiments, the inner layer 102 is a liquid impermeable, wherein the inner layer is made of a chemically compatible and / or biocompatible material selected from any, or combination of low-density polyethylene (LDP), Polyolefins, Fluoropolymersincluding Teflon (PTFE) and fluorinated ethylene propylene (FEP), or Thermoplastic elastomers (TPEs), Ethylene Vinyl Acetate copolymer, Teflon, or polypropylene.

[0084] In these embodiments, one or more middle layers 104 are made of material selected from any or a combination of film with black masterbatch, film with yellow masterbatch, Polyolefins, UV absorbers, Metal foils, Ceramic coatings, Carbon-based material, Nanocomposites, or Photonic crystals.

[0085] In these embodiments, the outer layer 106 is made of a structurally strong material selected from any, or a combination of High-density polyethylene (HDPE), Polypropylene (PP), Polyvinyl chloride (PVC), Acrylonitrile Butadiene Styrene (ABS), or Polyethylene Terephthalate (PET), metal sheet, glass or composite material.

[0086] In these embodiments, the bioprocess container (100) is single-use container with a shape selected from any or a combination of tank liner, powder bag, sampling bag, mixer bag, bioreactor, flat bag, pipe, or any other shape based on the light-sensitive content being held in the container.

[0087] In these embodiments, the bioprocess container (100) may be sterile or non- sterile.

[0088] FIG. 3 illustrates an exemplary view 300 of the proposed bioprocess container to protect an enclosed content from one or more radiations in a surrounding, in accordance with an embodiment of the present invention.

[0089] Referring to FIG. 3, where an exemplary view of the proposed container for use in bioprocess is shown.

[0090] In an embodiment, the bioprocess container 100 can include an inner layer 102 defining a hollow enclosure for the biomass; an outer layer 106 covering the inner layer 102 to protect the bioprocess container 100 from the external environment; and one or more middle layers 104 configured between the outer layer 106 and the inner layer 102.

[0091] In an embodiment, one or more middle layers 104 can be configured to block a range of wavelengths of light and ultra-violet rays that may negatively impact the outcome, to prevent degradation of bioprocesses, and the biomass held within the hollow enclosure. The biomass and the used media for the bioprocess are likely to degrade owing to factors like photo-oxidation or photo conversion due to the exposure of the biomass to light during the bioprocess. Bioprocesses are a stage-by-stage process that includes an initial stage, an intermediate stage, and an end stage where the required results are obtained. Each stage is where a plurality of activities, such as, but not limited to, taking samples, reaction of biomass with media, developments in biomass, etc. are performed during which the biomass may getexposed to light with harmful wavelengths. Therefore, it is desirable to protect the biomass as well as media from harmful light while retaining all the benefits of single-use systems.

[0092] In an embodiment, the undesirable range of wavelength of light and ultraviolet rays that are required to be blocked by the middle layers generally ranges from 200nm to l,100nm.

[0093] In an embodiment, the outer layer 106 can be made of structurally strong material to ensure puncture resistivity and blocking of penetration of molecules present in the surrounding environment.

[0094] In an embodiment, the inner layer 102 can be liquid impermeable, and biocompatible and / or chemically compatible.

[0095] In an embodiment, bioprocess container 100 can include one or more input ports 108 each configured with a fitting forming inlet passages for the number of biomasses required to be filled. The inlet port 108 can be used to feed the biomass to the bioprocess container 100 for bioprocesses by loosening the fitting, and tightening when biomass feeding is over.

[0096] In an embodiment, output port 112 can be used to harvest the biomass used in bioprocess, fully or partially, as and when required by loosening the fitting, and - tightening when the biomass harvesting process is over.

[0097] In an embodiment, one or more middle layers 104 can be made of one or more materials that withstand sterilization without degradation, and may be joined together to form a single layer to absorb and block undesirable range of wavelengths of light and ultraviolet rays. Also, as the biomass, when kept in the bioprocess container 100, is not in direct contact with one or more middle layers 104, it does not pose any risk of contamination from the middle layers 104, during the bioprocess.

[0098] In an embodiment, one or more middle layers 104 can be laminated to the outer layer 106, to use the bioprocess container 100 as a standard 2-layer bioprocessing bag. The outer layer 106 can be presumed as a stack of layers where one or more middle layer 104 are stacked over the outer layer 106. Also, one or more middle layers 104 can be selected to meet the requirement of cutting off different wavelengths for different bioprocesses.

[0099] In an embodiment, the bioprocess container 100 can vary in size as small as having a capacity of a few milliliters, such as for sampling, to as large as having a capacity of 1000 liters for specific bioprocess requirements.

[0100] In an embodiment, the invention can be used for making mixer and bioreactor bags, in addition to developing 2D / 3D bags, sampling bags, and powder bags, and used as a liner in many other bags for keeping bio products requiring protection against light.

[0101] In these embodiments, the bioprocess container 100 may include attachments needed for mixers and bioreactors such as spargers or impellers.

[0102] In an embodiment, the outer layer 106, the inner layer 102, and one or more middle layers 104 of bioprocess container 100 can be made of flexible materials to enable change in the shape of the bioprocess container 100 to a plurality of bag and shapes, such as but not limited to a 2-dimensional bag or 3 -dimensional bags, tank liners, powder bags, sampling bags and the like, and may range from a milliliter to thousands of liters in size. In these embodiments, the tank liners may not be fully enclosed.

[0103] In these embodiments, the light-sensitive content may include but is not limited to, biomass, cells, genes, and tissues extracted from a human, animal, and plant, as well as various chemicals in powder or liquid form.

[0104] In these embodiments, one or more middle layers may be made of one or more materials and joined together to form a single layer to absorb and block undesirable range of wavelengths of light and ultra-violet rays.

[0105] In these embodiments, one or more middle layers may be made of one or more materials that withstand sterilization without degradation.

[0106] In these embodiments, one or more middle layers may be laminated to the outer layer to use the container as a standard 2-layer bioprocessing bag.

[0107] In these embodiments, the outer layer may be a stack of layers and one or more middle layers are sandwiched within the stack of the outer layer.

[0108] FIG. 4 illustrates an exemplary graphical representation 400 showing the results of the absorption spectrum for fdm without one or more middle layers used for conventional containers (a), and the absorption spectrum for the fdm with one or more middle layers 104 used in the proposed bioprocess container (b), in accordance with an embodiment of the present invention.

[0109] Referring to FIG. 4, the sunlight, or light emitted by other sources like bulbs, is composed of a broad range of electromagnetic radiations of wavelengths in the ultraviolet, visible, and infra-red spectrum. These wavelengths cover a range generally, between 200nm to HOOnm and propagate with a certain amount of energy. When the biomass in the container made of a fdm is exposed to light, some of the energy is absorbed by the fdm andthe degree of absorption varies with each wavelength of the spectrum. Absorption may result in degradation of the biomass.

[0110] The study reveals that for the films without any light absorbent one or more middle layers 104 that are used for conventional containers, if exposed to light, the absorption of energy is highest between 200nm to around 300nm as shown by the curve 402 of FIG. 4a, and decreases for the wavelengths between 300nm to l,100nm. In the absence of absorption by the container, these radiations penetrate the walls of the container and reach the biomass, which may be sufficient to degrade the biomass. When one or more middle layers 104 are present in the film used for the containers, such as the disclosed bioprocess container 100, the absorption remains high for almost the full range of wavelengths ranging from 200nm to l,100nm as shown by curve 403 of FIG. 4b. This eliminates risk to the bioprocess as the energy does not reach the biomass on account of being absorbed by the one or more middle layers 104.[oni] Thus, the disclosed bioprocess container 100 is a simple and easy-to-use container for bioprocesses that blocks lights and UV rays falling between harmful ranges of wavelengths to protect the biomass. The cost-efficiency is obtained as degradation of the biomass is avoided.

[0112] FIG. 5 illustrates an exemplary representation 500 of one or more windows 112 (a) and the exemplary implementation of one or more patches 112-1 (b) in the bioprocess container 100, in accordance with an embodiment of the present invention.

[0113] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.ADVANTAGES OF THE PRESENT INVENTION

[0114] A general advantage of the present disclosure provides a simple, easy-to-use, and cost-effective solution to prevent the degradation of content such as yield that may be sensitive to light (UV or visible) while retaining all the benefits of single-use systems.

[0115] The present disclosure provides a solution to the problem of degradation of yield or quality of the content due to light exposure that does not require any additional parts / equipment.

[0116] The present disclosure provides a solution to the problem of degradation of content such as yield and quality due to light exposure that is not bulky.

[0117] The present disclosure provides a container that provides the desired yield by protecting the stored contents from wavelengths of radiation such as light or UV rays that may negatively impact the outcome.

[0118] The present disclosure provides a container made of flexible materials wherein the containers of various shapes and sizes meet the needs of different processes while simplifying logistics related to transport, storage, and disposal.

[0119] The present disclosure provides a sterilizable container for applications like food and drug manufacturing, where sterilization may be conducted via Gamma irradiation, Ethylene Oxide treatment, or other such techniques.

[0120] The present disclosure provides a container that is preferably used in the lab and for industrial-scale bioprocess manufacturing techniques, such as those used for food and drug production. Such techniques would encompass areas such as cell and gene therapy production as well, which utilize equipment and methodologies found in bioprocess-based manufacturing but may not be bioprocess-based.

[0121] The present disclosure provides a container that does not contaminate or react with the internal light-sensitive contents.

[0122] The present disclosure provides a container that protects the internal light- sensitive contents from contamination or reaction with external contents, such as endotoxins, bacteria, oxygen, carbon dioxide, and the like.

Claims

We Claim:

1. A bioprocess container (100) to protect an enclosed content from one or more radiations in a surrounding, the bioprocess container (100) comprising: an enclosure (600) made of a plurality of layers (110) having at least one port (108) to receive a content for enclosing in the enclosure (600) or to exit the enclosed content from the enclosure (600); wherein one or more middle layers (104) of the plurality of layers (110) are sandwiched between an outer layer (106) and an inner layer (102) of the plurality of layers (110) such that the inner layer (102) receives the content for enclosing; and wherein the outer layer (106) is adapted to provide structural support, and at least one layer of the one or more middle layers (104) is adapted to prohibit entry of one or more radiations from the surrounding in the inner layer (102), and the inner layer (102) is biologically and / or a chemically compatible layer with the enclosed content.

2. The bioprocess container (100) as claimed in claim 1, wherein: the one or more radiations are selected from any or a combination of ultraviolet (UV) radiation, visible light, infrared (IR) radiation, X-rays, gamma rays, or microwaves; and the plurality of layers (110) is adapted to prohibit exchange of one or more molecules with the surrounding, wherein the one or more molecules are selected from any or a combination of oxygen, carbon dioxide, nitrogen, water vapor, particulate matter, contaminants, microorganisms, endotoxins, or particles.

3. The bioprocess container (100) as claimed in claim 1, wherein: the inner layer (102) is a chemically and / or biologically compatible layer, wherein the inner layer (102) is made of a biocompatible material selected from any, or combination of low-density polyethylene (LDPE), ultra-low-density polyethylene (ULDPE), high-density polyethylene (HDPE), Polyolefins, Fluoropolymers including Teflon (PTFE) and fluorinated ethylene propylene (FEP), or Thermoplastic elastomers (TPEs), Ethylene Vinyl Acetate copolymer, Teflon, or polypropylene; the one or more middle layers (104) are made of a material adapted to prohibit entry of one or more radiations, wherein one or more middle layers (104) are selected from any or a combination of film with black masterbatch, film with yellowmasterbatch, film with coloured masterbatch, polyolefins, UV absorbers, metal foils, metal coatings, ceramic coatings, carbon-based material, nanocomposites, or photonic crystals; and the outer layer (106) is a support layer for the enclosed content, wherein the outer layer (106) is made of a structurally strong material selected from any, or a combination of High-density polyethylene (HDPE), Polypropylene (PP), Polyolefins, Ethylene Vinyl Acetate copolymer (EVA), Polyvinyl chloride (PVC), Acrylonitrile Butadiene Styrene (ABS), or Polyethylene Terephthalate (PET), metal sheet, glass or composite material.

4. The bioprocess container (100) as claimed in claim 1, wherein the one or more middle layers (104) are co-extruded and / or laminated to each other to form a single middle layer; the one or more middle layers (104) are co-extruded and / or laminated to the outer layer (106) to form one single outer layer (106); the one or more middle layers (104) are co-extruded and / or laminated to the inner layer (106) to form one single inner layer (106); or the inner layer (102), the outer layer (106), and the one or more middle layers (104) are co-extruded and / or laminated to each other to form a single layer.

5. The bioprocess container (100) as claimed in claim 1, wherein r the bioprocess container (100) further comprising: one or more non-opaque windows (112) attached on the one or more middle layers (104), adapted to facilitate a visual inspection and / or an optical analysis of the enclosed content; and one or more patches (112-1) are attached to the outer side of the one or more non- opaque windows (112) to protect the enclosed contents from radiation exposure through the windows (11), and the patches (112-1) may be moved to expose the windows (112) when needed.

6. The bioprocess container (100) as claimed in claim 1, wherein: the bioprocess container (100) is a single-use container having a shape selected from any or a combination of tank liner, powder bag, sampling bag, mixer bags, single-usebioreactor, 2D bags, 3D bags, flat bag, pipe or any other shape based on the content being held in the container; and7. The bioprocess container (100) as claimed in claim 1, wherein the enclosed content is selected from any or a combination of one or more pharmaceutical products, one or more biological samples including biomass, cell, gene, DNA and tissue, or one or more chemical reagents in a solid form or a liquid form.

8. The bioprocess container (100) as claimed in claim 1, wherein the bioprocess container (100) further comprises one or more attachments (114) for processing and / or monitoring the enclosed contents, wherein the one or more attachments (114) are selected from any or a combination of ports, tubes, spargers, impellers, sensors, or filters.

9. A method (200) of protecting an enclosed content from one or more radiations in a surrounding using a bioprocess container (100), the method (200) comprising: providing (202) an enclosure (600) having a plurality of layers (110), wherein the enclosure comprises at least one port (108) to receive a content for enclosing in the enclosure (600), and to exit the enclosed content from the enclosure (600); sandwiching (204) one or more middle layers (104) of the plurality of layers (110) between an outer layer (106) and an inner layer (102) of the plurality of layers (110) such that the inner layer (102) receives the content for enclosing; providing (206), by the outer layer (106), structural support for the enclosed content inside the enclosure (600); and prohibiting (208), by at least one layer of the one or more middle layers (104), entry of one or more radiations from the surrounding in the inner layer (102); and providing (210), by the inner layer (102), biological and / or chemical compatibility with the enclosed content.

10. The method (200) as claimed in claim 8, wherein: the one or more radiations are selected from any or a combination of ultraviolet (UV) radiation, visible light, infrared (IR) radiation, X-rays, gamma rays, or microwaves;the one or more molecules are selected from any, or a combination of oxygen, carbon dioxide, water vapor, particulate matter, contaminants, microorganisms, endotoxins, or particles; the bioprocess container (100) is a single-use container with a shape selected from any or a combination of tank liner, powder bag, sampling bag, single-use bioreactor, flat bag, pipe, or any other shape based on the light-sensitive content being held in the container; the inner layer (102) is made of a biocompatible material selected from any, or combination of low-density polyethylene (LDP), Polyolefins, Fluoropolymers including Teflon (PTFE) and fluorinated ethylene propylene (FEP), or Thermoplastic elastomers (TPEs), Ethylene Vinyl Acetate copolymer, Teflon, or polypropylene; the one or more middle layers (104) are made of a material selected from any or a combination of film with black masterbatch, film with yellow masterbatch, film with coloured masterbatch, polyolefins, UV absorbers, metal foils, metal coatings, ceramic coatings, carbon-based material, nanocomposites, or photonic crystals; and the outer layer (106) is made of a structurally strong material selected from any, or a combination of High-density polyethylene (HDPE), Polypropylene (PP), Polyvinyl chloride (PVC), Acrylonitrile Butadiene Styrene (ABS), or Polyethylene Terephthalate (PET), metal sheet, glass or composite material.

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