SYSTEMS AND METHODS FOR FREEZING, STORING AND THAWING BIOPHARMACEUTICAL MATERIAL
A system for controlled freezing, storing and thawing a biopharmaceutical material includes a flexible container and a supporting structure. The flexible container is adapted to receive the biopharmaceutical material therein for freezing, storing and thawing. The container further includes a flange and the supporting structure is engageable with the flange to receive the container. The supporting structure may position the container for freezing and may protect it during transport and storage.
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This application is a Continuation of U.S. application Ser. No. 11/501,329, filed on Aug. 9, 2006, and titled “Systems And Methods for Freezing, Storing, Transporting And Thawing Biopharmaceutical Material”, which is a Continuation of U.S. application Ser. No. 10/455,223, filed on Jun. 4, 2003, and titled “Systems and Methods for Freezing, Storing, Transporting and Thawing Biopharmaceutical Material”, which is a Continuation in part of U.S. application Ser. No. 10/254,036, filed on Sep. 23, 2002 and titled “Systems and Methods for Freezing, Storing and Thawing Biopharmaceutical Material”, now U.S. Pat. No. 6,698,212, which claims the benefit of U.S. Provisional Application No. 60/334,622, filed Nov. 1, 2001, all of which are incorporated herein by reference. Also, U.S. application Ser. No. 10/455,223 is a Continuation in part of U.S. application Ser. No. 10/254,025 filed on Sep. 23, 2002 and titled “Systems and Methods for Freezing, Storing, and Thawing Biopharmaceutical Material”, now U.S. Pat. No. 6,684,646, which claims the benefit of U.S. Provisional Application No. 60/334,622, filed Nov. 1, 2001, all of which are incorporated herein by reference. Also, the contents of U.S. patent application Ser. No. 09/905,488, filed Jul. 13, 2001, entitled “Cryopreservation System with Controlled Dendritic Freezing Front Velocity”, now U.S. Pat. No. 6,453,683, and U.S. patent application Ser. No. 09/863,126, entitled “Cryopreservation System with Controlled Dendritic Freezing Front Velocity”, filed May 22, 2001, now U.S. Pat. No. 6,635,414, are incorporated herein by reference. This application also relates to U.S. patent application Ser. No. 10/455,222, filed on Jun. 4, 2003, and titled “Systems And Methods For Freezing, Storing And Thawing Biopharmaceutical Material,” now U.S. Pat. No. 6,945,056, the contents of which are incorporated herein by reference.
TECHNICAL FIELDThis invention relates, in general, to biopharmaceutical materials, preservation methods and systems, and more particularly to systems and methods for transporting, freezing, storing, and thawing of biopharmaceutical materials.
BACKGROUND ARTPreservation of biopharmaceutical materials is important in the manufacture, storage, sale and use of such materials. For example, biopharmaceutical materials are often preserved by freezing between processing steps and during storage. Similarly, biopharmaceutical materials are often frozen during transportation between manufacturing locations.
Currently, preservation of biopharmaceutical material often involves placing a container containing liquid biopharmaceutical material in a cabinet freezer, chest freezer or walk-in freezer and allowing the biopharmaceutical material to freeze. Specifically, the container is often placed on a shelf in the cabinet freezer, chest freezer or walk-in freezer and the biopharmaceutical material is allowed to freeze. These containers may be stainless-steel vessels, plastic bottles or carboys, or plastic bags. They are typically filled with a specified volume to allow for freezing and expansion and then transferred into the freezers at temperatures typically ranging from negative 20 degrees Celsius to negative 70 degrees Celsius or below.
To ensure efficient use of available space inside the freezer, containers are placed alongside one another and sometimes are stacked into an array with varied spatial regularity. Under these conditions, cooling of the biopharmaceutical solution occurs at different rates depending on the exposure of each container to the surrounding cold air, and the extent to which that container is shielded by neighboring containers. For example, containers placed close to the cooling source or those on the outside of an array of containers would be cooled more rapidly than those further away from the cooling source and/or situated at the interior of the array.
In general, adjacent placement of multiple containers in a freezer creates thermal gradients from container to container. The freezing rate and product quality then depend on the actual freezer load, space between the containers, and air movement in the freezer. This results in a different thermal history for the contents of the containers depending on their location in a freezer, for example. Also, the use of different containers for individual portions of a single batch of biopharmaceutical material may cause different results for portions of the same batch due to different thermal histories resulting from freezing in a multiple container freezer, particularly if the storage arrangement is haphazard and random. Another consequence of obtaining a range of freezing times is that certain containers may freeze so slowly that the target solute can no longer be captured within the ice phase, but remains in a progressively smaller liquid phase. This phenomenon is referred to as “cyroconcentration.” In some cases such cyroconcentration could result in precipitation of the biopharmaceutical product, thus resulting in product loss.
Disposable containers such as plastic bags or other flexible containers often are damaged, leading to loss of the biopharmaceutical material. Particularly, the volumetric expansion of the biopharmaceutical materials during freezing could generate excessive pressure in an over filled bag or in a pocket of occluded liquid adjoining the bag material, possibly leading to rupture or damage to the integrity of the bag. Moreover, handling of such disposable containers, such as plastic bags, during freezing, thawing, or transportation of these containers often result in damage thereof, due, for example, to shock, abrasion, impact, or other mishandling events arising from operator errors or inadequate protection of the bags in use.
Thus, there is a need for systems and methods for freezing, storing, and thawing of biopharmaceutical materials that are controlled, do not result in loss of biopharmaceutical material, but instead create conditions conducive to preserving the biopharmaceutical material in a uniform, repeatable fashion in a protected environment.
SUMMARY OF THE INVENTIONThe present invention provides, in a first aspect, a container for freezing, storing and thawing a biopharmaceutical material, which is receivable in a frame for supporting and protecting said container. The container includes a material adapted to receive the biopharmaceutical material therein for freezing, storing and thawing in liquid or frozen state, and the container includes a flange connectable to the support frame for supporting the flexible container in the support frame.
The present invention provides, in a second aspect, a system for freezing, storing and thawing a biopharmaceutical material which includes a container and a frame. The container is adapted to receive the biopharmaceutical material therein and the container includes a flange. The frame is adapted to receive the container and is engagable with the flange.
The present invention provides, in a third aspect, a method for freezing, storing and thawing a biopharmaceutical material. The method includes providing a container adapted to contain the biopharmaceutical material for freezing, storing and thawing, and positioning the container in a frame for supporting and protecting the container.
The present invention provides, in a fourth aspect, a system for freezing, storing and thawing a biopharmaceutical material which includes a container adapted to receive the biopharmaceutical material therein for freezing, storing and thawing. The container is adapted to receive a support member for supporting the container.
The present invention provides, in a fifth aspect, a method for freezing, storing and thawing a biopharmaceutical material. The method includes providing a container adapted to contain the biopharmaceutical material for freezing, storing and thawing and connecting a sleeve of the container to a support member.
The present invention provides, in a sixth aspect, a system for freezing, storing and thawing a biopharmaceutical material which includes a container adapted to receive biopharmaceutical material therein for freezing and subsequent thawing. The container is configured to conform to the shape of an interior of a temperature control unit, when the container is substantially filled with the biopharmaceutical material, and/or the shape of a protective structure adapted to receive the container.
The present invention provides, in a seventh aspect, a system for freezing, storing and thawing a biopharmaceutical material which includes a flexible container adapted to contain the biopharmaceutical material. The flexible container is adapted to substantially conform to a shape of a first interior of a temperature control unit and is adapted to substantially conform to a second interior of a storage vessel.
The present invention provides, in a eighth aspect, a method for freezing, storing and thawing a biopharmaceutical material which includes providing a sterile container adapted to contain the biopharmaceutical material for freezing and configuring the sterile container to conform to a shape of an interior of a temperature control unit.
The present invention provides, in a ninth aspect, a system for storing a biopharmaceutical material which includes a flexible container configured to contain the biopharmaceutical material for freezing wherein the flexible container further includes means for engaging with at least one of a temperature control unit and a storage vessel for supporting the flexible container.
The present invention provides, in a tenth aspect, a system for freezing, storing and thawing biopharmaceutical material which includes a flexible container, a conduit, and a temperature control unit. The flexible container is adapted to receive a liquid biopharmaceutical material therein for freezing, storing and thawing, wherein the container fully encloses an interior portion for receiving the biopharmaceutical material. Also, the container is configured to form a three-dimensional shape when filled with the biopharmaceutical material wherein the three dimensional shape has a first side and a second side opposite the first side. The conduit is connected to the flexible container to allow the outside of the container to be in fluid communication with the interior portion via the conduit. The temperature control unit includes a first surface and a second surface facing the first surface. Also, the temperature control unit is configured to receive the flexible container therein, when the container is filled with the biopharmaceutical material. The container conforms to the shape of the interior of the temperature control unit and the first side and the second side of the container contact the first surface and the second surface of the temperature control unit, when the container is substantially filled with the biopharmaceutical material. The first and/or second surfaces of the temperature control unit include a heat transfer surface.
BRIEF DESCRIPTION OF THE DRAWINGSThe subject matter which is regarded as the invention is particularly pointed out and distinctly claimed in the claims at the conclusion of the specification. The foregoing and other features, and advantages of the invention will be readily understood from the following detailed description of preferred embodiments taken in conjunction with the accompanying drawings in which:
In accordance with the principles of the present invention, systems and methods for freezing, storing and thawing biopharmaceutical materials are provided.
In an exemplary embodiment depicted in
Flexible container 10 may be formed of a laminated film which includes a plurality of layers and may have an interior volume ranging from 0.01-100 liters, for example. Further, flexible container 10 could be available in a variety of sizes to accommodate different uses, for example, 5, 10, and 20 liter flexible containers may be utilized. Also a biocompatible product-contacting layer of the interior of flexible container 10 may be formed of a low density polyethylene, very low density polyethylene ethylene vinyl acetate copolymer, polyester, polyamide, polyvinylchloride, polypropylene, polyfluoroethylene, polyvinylidenefluoride, polyurethane or fluoroethylenepropylene, for example. A gas and water vapor barrier layer may also be formed of an ethylene/vinyl alcohol copolymer mixture within a polyamide or an ethylene vinyl acetate copolymer. Further, flexible container 10 may include a layer with high mechanical strength (e.g. a polyamide), and an external layer with insulating effect to heat welding, for example, polyester. The layers may be compatible with warm and cold conditions and may be able to withstand ionizing irradiation for sterilization purposes. Also, flexible container 10 may have a large surface area to volume ratio, and a relatively thin wall thus promoting heat transfer therethrough when received in temperature control unit 20. One example of materials useful for formulation of flexible container 10 is described in U.S. Pat. No. 5,988,422 to Vallot, the entire subject matter of which is hereby incorporated herein by reference. Also, flexible container 10 may be disposable, thus promoting ease of use and preventing cross-contamination of the interior of flexible container 10 which might result when reusing other types of containers.
Sterile, flexible container 10 may be adapted to be received in frame 15 for supporting flexible container 10. For example, flexible container 10 may include an outwardly-extending flange 100 adapted to be received in a channel 200 of frame 15, as depicted in
Further, flexible container 10 may include a vertically extending flange or rod (not shown) projecting from a top side 11 of flexible container 10. The vertically extending flange may be configured to be received in channel 200 and may be substantially perpendicular to flange 100. The vertically extending flange also may be configured to connect to a top portion of frame 15 to reduce sag of flexible container 10 when flexible container 10 is received in frame 15.
Flexible container 10 may also include a tab 110 or other means for receiving a label to provide an indication to a user as to the contents of flexible container 10. Such a label may include written information, an embedded microchip, a RF transmitter and/or an electronic or magnetic bar code for indication of the contents of flexible container 10 to facilitate identification, tracking, and/or characterization of the contents thereof. The use of the label may thus simplify management of materials stored in flexible container 10, received in frame 15, when it is stored in a large freezer containing other frames and flexible containers which may appear similar thereto.
As shown in
Temperature control unit 20 is configured to control the temperature of an interior 25 thereof, as depicted in
In a preferred embodiment, temperature control unit 20 is a heat exchanger having one or more conduction plates for heating and/or cooling flexible container 10 and biopharmaceutical materials contained therein, as depicted in
Frame 15 may be formed to receive and support flexible container 10 to provide additional rigidity and support to flexible container 10, thus facilitating handling, storage, and/or temperature control thereof. Frame 15 may include a first opening 210 and a second opening 211 (
Also, flexible container 10 may be adapted to be compressed by plates 28, (
Frame 15 may further include upwardly extending sides 260, a bottom 270 and a top 280 to protect and support flexible container 10. Top 280 may be hingedly attached to frame 15 allow top 280 to be opened and allow flexible container 10 to be inserted into interior 240, and top 280 may be closed to protect flexible container 10. Also, top 280 may include a handle 285, as best depicted in
For example, sides 260 may be formed of fluoropolymer resin (i.e. TEFLON) and top 280 and bottom 270 may be formed of stainless steel. Also, sides 260, bottom 270 and/or top 280 may be made of any number of other materials including aluminum, polyethylene, polypropylene, polycarbonate, and polysulfone, for example. Further materials may include composite materials such as glass-reinforced plastic, carbon-fiber reinforced resins, or other engineering plastic materials known to offer high strength-to-weight rations and which are serviceable at various temperatures of interest. It will be understood by those skilled in the art that sides 260, bottom 270 and/or top 280 may be monolithic and integrally formed as one piece or suitably connected together. Further, sides 260, bottom 270 and/or top 280 could be formed of a same material (e.g. stainless steel) or they could be formed of different materials and connected together. Frame 15 may also include one or more foot members 14 for maintaining frame 15 in an upright position, as depicted in
Further, frame 15 may be adapted to be received in a protective structure or cover 250 to protect flexible container 10, as depicted in
Frame 15 may also hold ancillary equipment and tubing. For example, as depicted in
Moreover, frame 15 may be adapted to be received in a storage unit or a transportation device, such as a cart 290, as depicted in
Temperature control unit 20 may also include a frame advancing mechanism to advance frame 15 outside of interior 25 of temperature control unit 20, which may be activated by a lever 23, as depicted in
Frame 15 may secure flexible container 10 in a defined position. Such arrangement facilitates the handling and transportation of liquid filled flexible container 10. In particular, the filling and drainage operation are facilitated by the self-standing position of flexible container 10 supported by frame 15, when supported by foot members 14. Alternatively, flexible container 10 may be filled and/or drained while frame 15 having flexible container 10 therein is located inside cart 290. Classically, liquid filled flexible containers are drained by gravity. Flexible containers are usually hung upside down or at least tilted to permit a complete drainage. This operation may be unsafe and/or cumbersome due to weight constraints, for example, for flexible containers with volumes higher than 10 liters. Thus, it may be desirable to hold higher volume containers in self-standing frames to facilitate drainage thereof.
In another embodiment of the present invention, a flexible container 350 for holding biopharmaceutical material therein may be adapted to be received in a frame 360 for supporting flexible container 350, as depicted in
Flexible container 350 may also include one or more tie-down loops 450 connectable to frame 15 via tie-down bosses 460 (
Also, flexible container 350 may include one or more ports or conduits 355 to allow insertion or extraction of biopharmaceutical liquids or other liquids or gases into and/or out of an interior (not shown) of flexible container 350. Referring to
Top 400 may include a handle 402 to allow a user to carry flexible container 350, when flexible container 350 is received in frame 360, with or without flexible container 350 being substantially filled with biopharmaceutical material. Top 400 may also be adapted to be connected to flexible container 350 to allow top 400 to support flexible container 350, without flexible container 350 being connected to left side 370 right side 380, or bottom side 390, as depicted in
In another embodiment of the present invention, a frame 600 may include a first portion 610 and a second portion 620 adapted to be connected or clamped to one another, as depicted in
Flexible container 630 may include one or more ports or conduits 635 to allow filling or draining of biopharmaceutical liquids or other liquids or gases into and/or out of an interior (not shown) of flexible container 630. Flexible container 630 may also include a tag or label 680 protruding from frame 600 to indicate to a user the contents of flexible container 10, when such a label or indicator is attached to flexible container 630. Also, a pivoting side 612 of first portion 610 may be openable to allow flexible container 630 to overhang a bottom side 614 of first portion 610, when flexible container 630 is not substantially filled with biopharmaceutical material. This allows flexible container 630 to be extended to minimize slack or wrinkles in flexible container 630, during filling thereof. After flexible container 630 is substantially filled with biopharmaceutical material, any slack in flexible container 630 may be taken up and flexible container 630 may not overhang bottom side 614. Thus, pivoting side 612 may be closed, when flexible container 630 is substantially filled with the biopharmaceutical material, to protect a bottom portion of flexible container 630 from contact with any external objects.
In a further embodiment of the present invention, a flexible container 700 for holding biopharmaceutical materials may include one or more sleeves 710 for receiving a support member 720 for supporting flexible container 700, as depicted in
As depicted in
Although the containers are described herein as flexible containers, the containers may be made of a semi-rigid material such as polyethylene or the like. Such a semi-rigid material may retain its shape and/or stand up by itself when empty and when filled with a biopharmaceutical material. An example of such a container could include a container similar to a standard plastic milk jug. Containers made of such similar semi-rigid materials may benefit from additional rigidity supplied by attachment to a frame, for example. Further, the containers whether formed of a flexible or semi-rigid material, contain outer surfaces which contact the interior surfaces (e.g., heat transfer plates) of a temperature control unit 20 so that there is direct contact between the cooled (e.g., to a subzero temperature) or heated interior surfaces of temperature control unit 20 and the outer surfaces of the container containing biopharmaceutical materials. Alternatively, the outer surfaces of the containers for holding the biopharmaceutical materials may be in contact with air flow in interior 25 of temperature control unit 20 to cause the cooling and/or heating of the containers having the biopharmaceutical materials therein to cause the temperature of the biopharmaceutical materials to be controlled.
The biopharmaceutical material in the flexible containers described above may thus be cooled or otherwise thermoregulated in temperature control unit 20 (e.g., to a subzero temperature). When such operation is completed, the flexible containers may be removed from temperature control unit 20 by removing the flexible containers and the frames, or other support structures which the flexible containers are received in or connected to, for example. The frames or other support structures holding the flexible containers may be stored in a large chiller or freezer with an interior air temperature of about negative 20 degrees Celsius, for example.
Also, the biopharmaceutical material in the flexible containers described above may be removed from and/or inserted therein by rotating the position of the flexible containers. For example, as depicted in
A typical process of processing and/or preserving a biopharmaceutical material is described as follows. Flexible container 10 is inserted into frame 15 and top 280 is closed, as depicted in
It will be evident to those skilled in the art from the above description that flexible container 350 (
Further, the above described flexible containers may be removed from a freezer or other system for storage of the flexible containers and contents thereof at a controlled temperature. These flexible containers having biopharmaceutical material therein may then be received in a controlled temperature control unit for heating, melting, and/or thawing the biopharmaceutical material contained in the flexible containers.
In another embodiment of the present invention, depicted in
Temperature control unit 1020 is configured to be operatively coupled to a temperature regulating unit 1027 for controlling fluid flow through a conductive medium, such as heat transfer plates 1040 of temperature control unit 1020 to control the temperature of an interior 1025 thereof. A controller 1050 allows a user to control temperature regulating unit 1027 to control heating and/or cooling of the conductive medium, such as plates 1040, to cause freezing or thawing, for example, of biopharmaceutical materials in a container such as flexible container 1010, when it is inserted into interior 1025 of temperature control unit 1020. Controller 1050 may also be coupled to a temperature sensor (not shown) located in interior 1025 of temperature control unit 1020. The temperature sensor may be located on one or more of plates 1040, for example, and may provide temperature feedback to controller 1050 to facilitate control of temperature regulating unit 1027. One example of a temperature control unit 1020 is described in co-owned U.S. patent application Ser. No. 09/905,488 filed Jul. 13, 2001, and co-owned U.S. patent application Ser. No. 09/863,126, filed May 22, 2001, the entirety of each of which is hereby incorporated herein by reference. The cooling systems described in the aforementioned applications, and freezing and/or thawing techniques described therein, may be used in conjunction with the systems and methods of freezing, storing and thawing biopharmaceutical materials of the present invention. Specifically, the cryogenic coolers or heat exchangers described in these applications may be configured to incorporate and/or receive the containers for storing biopharmaceutical materials described herein and any associated structures.
Flexible container 1010 may be configured to conform to the shape of interior 1025 of temperature control unit 1020. Specifically, flexible container 1010 may conform to interior 1025 such that any space or voids between flexible container 1010 and heat transfer plates 1040 might be reduced or prevented. For example, flexible container 1010 when substantially filled may form a parallelepiped shape. Further, flexible container 1010 may be configured such that it can conforms to shapes of interiors other than that of interior 1025 such that any spaces or voids between flexible container 1010 and heat transfer plates in such other shaped containers might be reduced or prevented. Although the containers are described herein as flexible containers, the containers may be made of a semi-rigid material. Such material may be used to construct a container which is shaped to conform to the interior of temperature control unit 1020. Preferably, the container whether formed of a flexible or semi-rigid material, contains surfaces which contact the interior surfaces (e.g., heat transfer plates) of temperature control unit 1020 so that there is direct contact between the cooled (or heated in a thawing process) surfaces of the temperature control unit and the outer surfaces of the container containing biopharmaceutical materials.
In one example, flexible container 1010 when substantially filled, may form a parallelepiped shape. Flexible container 1010 may be formed by welding of several sheets of material to form the parallelepiped shape, as depicted in
In another example, a flexible container 1015 used as a container for freezing, storing and thawing biopharmaceutical materials is depicted in
Although pins are specifically mentioned herein, it will be understood by those skilled in the art that flexible container 1010 or another container may be used with or without holder 1200, and that other means of securing flexible container 1010 to the holder 1200 such as clamps, or other fastening systems may be used. Moreover, although the container is described herein as a flexible container, the container may be made of a semi-rigid material. Such material may be used to construct a container which is shaped to conform to the interior of temperature control unit 1020. Preferably, the container whether formed of a flexible or semi-rigid material, contains surfaces which contact the interior surfaces (e.g., heat transfer plates) of temperature control unit 1020 so that there is direct contact between the cooled (or heated in a thawing process) surfaces of the temperature control unit and the outer surfaces of the container containing biopharmaceutical materials.
Referring to
Vessel 1060, thus, may receive an empty, sterile, flexible container 1010. The flexible container 1010 may be filled via tube 1330 with biopharmaceutical material before flexible container 1010 is transferred to temperature control unit 1020 (
The bottom of vessel 1060 may contain one or more notches 1324 as depicted in
In another embodiment of the invention, support structure 1032 of
In a further embodiment of the present invention, a temperature control unit 1500 may include a plurality of receiving interior portions 1510 for receiving a plurality of flexible containers 1515 adapted to contain biopharmaceutical material, as depicted in
A temperature control unit 1501, similar to that depicted in
Another example of a system for freezing, thawing, storage and preservation of a biopharmaceutical material is depicted in
Another example of a process for freezing, thawing, storing and preserving biopharmaceutical material is described as follows. Flexible container 1010 is inserted into support structure 1032 (
From the above description, it will be understood to one skilled in the art that the flexible containers described herein may be adapted for use in containers, frames, storage units, support structures, transportation devices, temperature control units, heat exchangers, vessels, and/or processors of various shapes or sizes. Further, the frames, containers, support structures, heat exchangers, temperature control unit, vessels, and/or processors may be adapted to receive flexible containers of various shapes or sizes. These frames, vessels, or support structures may be adapted for long or short term storage of the flexible containers containing biopharmaceutical materials in liquid or frozen state, or may be adapted to transport the flexible containers containing biopharmaceutical materials in liquid or frozen state. For example, the storage units, vessels, or transportation devices may be insulated to allow the material to remain at a given temperature for a prolonged period of time. Furthermore, these flexible containers, frames, containers, support structures, temperature control units, heat exchangers, and/or processors may be adapted for utilization with materials other than biopharmaceutical materials. Finally, the storage containers, support structures, vessels, or frames may be equipped with various transport mechanisms, such as wheels, glides, sliders, dry-ice storage compartments or other devices to facilitate transport and organization thereof.
While the invention has been depicted and described in detail herein, it will be apparent to those skilled in the relevant art that various modifications, additions, substitutions and the like can be made without departing from the spirit of the invention and these are therefore considered to be within the scope of the invention as defined in the following claims.
Claims
1. A system for freezing, storing and thawing a biopharmaceutical material, said system comprising:
- a container means for receiving biopharmaceutical materials therein;
- a support member forming a cavity configured to receive said container means therein and to support a weight of said container means when said container means holds biopharmaceutical materials; and
- said cavity bounded by inner surfaces of said support member facing each other and by covering portions releasably engaged with said support member, said covering portions located opposite each other about said cavity and configured to allow flattening of said container means within said cavity.
2. The system of claim 1 wherein said covering portions are connected to each other by a connecting member.
3. The system of claim 2 wherein said covering portions are aligned substantially parallel to each other and said connecting member is aligned substantially perpendicular to said covering portions.
4. The system of claim 1 wherein opposite ends of a first covering portion of said covering portions are spaced from opposite ends of a second covering portion of said covering portions.
5. The system of claim 1 wherein said support member comprises feet allowing said support member to stand independently.
6. The system of claim 1 wherein said container means contains biopharmaceutical materials and said container means abuts said covering portions.
7. The system of claim 1 wherein said container means contains biopharmaceutical materials and said container means contacts said inner surfaces and said covering portions to substantially inhibit space between said container means and said inner surfaces and said covering portions.
8. The system of claim 1 wherein said container means is connected to said support member such that said container means is suspended from said support member in said cavity.
9. The system of claim 8 wherein said container means is suspended such that a height of said container means is substantially aligned with a height of said support member.
10. The system of claim 8 wherein said container means comprises a flange connected to said support member, said flange configured to support said weight of said container material when said flange is connected to said support member and said container means holds said biopharmaceutical materials.
11. The system of claim 1 wherein said container means is flexible in response to receiving the biopharmaceutical materials.
12. A system for freezing, storing and thawing a biopharmaceutical material, said system comprising:
- a container means for receiving biopharmaceutical materials therein;
- a support member forming a cavity configured to receive said container means therein and to support a weight of said container means when said container means holds biopharmaceutical materials;
- said cavity bounded by inner surfaces of said support member facing each other and by covering portions located opposite each other about said cavity; and
- means for flattening said container means within said cavity.
13. The system of claim 12 wherein said covering portions are connected to each other by a connecting member.
14. The system of claim 13 wherein said covering portions are aligned substantially parallel to each other and said connecting member is aligned substantially perpendicular to said covering portions.
15. The system of claim 12 wherein opposite ends of a first covering portion of said covering portions are spaced from opposite ends of a second covering portion of said covering portions.
16. The system of claim 12 wherein said support member comprises feet configured to allow said support member to stand independently.
17. The system of claim 12 wherein said container means contains biopharmaceutical materials and said container means abuts said covering portions.
18. The system of claim 12 wherein said container means contains biopharmaceutical materials and said container means contacts said inner surfaces and said covering portions to substantially inhibit space between said container means and said inner surfaces and said covering portions.
19. The system of claim 12 wherein said container means is connected to said support member such that said container means is suspended from said support member in said cavity.
20. The system of claim 19 wherein said container means is suspended such that a height of said container means is substantially aligned with a height of said support member.
21. The system of claim 19 wherein said container means comprises a flange connected to said support member, said flange configured to support said weight of said container material when said flange is connected to said support member and said container means holds said biopharmaceutical materials.
22. The system of claim 12 wherein said container means is flexible in response to receiving the biopharmaceutical materials.
23. A method for freezing, storing and thawing biopharmaceutical material, the method comprising:
- providing a container means for receiving biopharmaceutical materials therein;
- receiving the container means in a cavity of a support member and supporting a weight of the container means by the support member when the container means holds biopharmaceutical materials;
- the cavity bounded by inner surfaces of the support member facing each other;
- releasably engaging covering portions with the support member such that the covering portions are located opposite each other about the cavity; and
- flattening the container means between the covering portions and within the cavity.
24. The method of claim 23 further comprising connecting the covering portions to each other by a connecting member.
25. The method of claim 24 wherein the covering portions are aligned substantially parallel to each other and the connecting member is aligned substantially perpendicular to the covering portions.
26. The method of claim 23 wherein opposite ends of a first covering portion of the covering portions are spaced from opposite ends of a second covering portion of the covering portions.
27. The method of claim 23 further comprising standing the support member independently on feet of the support member.
28. The method of claim 23 further comprising receiving biopharmaceutical materials in the container means, freezing the biopharmaceutical materials and maintaining the frozen biopharmaceutical materials entirely within the cavity.
29. The method of claim 23 further comprising receiving biopharmaceutical materials in the container means and abutting the container means with the covering portions.
30. The method of claim 23 receiving biopharmaceutical materials in the container means and abutting the container means with the inner surfaces and said covering portions to substantially inhibit space between the container means and the inner surfaces and the covering portions.
31. The method of claim 23 wherein the container means is connected to the support member such that the container means is suspended from the support member in the cavity.
32. The method of claim 31 wherein the container means is suspended such that a height of the container means is substantially aligned with a height of the support member.
33. The method of claim 31 wherein the container means comprises a flange connected to the support member, the flange configured to support the weight of the container material when the flange is connected to the support member and the container means holds the biopharmaceutical materials.
34. The method of claim 23 wherein the container means is flexible in response to receiving the biopharmaceutical materials.
Type: Application
Filed: Oct 10, 2006
Publication Date: Jun 7, 2007
Applicant: INTEGRATED BIOSYSTEMS, INC. (Napa, CA)
Inventors: Nicolas VOUTE (Chemin Peygros), Maxime LOK (Marseille), David BROWN (Chicago, IL), James KENDALL (Mount Prospect, IL), Edward GEISELHART (Chicago, IL)
Application Number: 11/548,182
International Classification: F25D 25/00 (20060101); F25D 3/08 (20060101);