Systems and methods for freezing, storing and thawing biopharmaceutical materials

Patent metadata

Field	Value
Publication number	US-9301520-B2
Application number	US-96310607-A
Country	US
Kind code	B2
Filing date	Dec 21, 2007
Priority date	Dec 21, 2007
Publication date	Apr 5, 2016
Grant date	Apr 5, 2016

Abstract

A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

First claim

The invention claimed is:

1. A system for use in freezing, storing and thawing biopharmaceutical materials, said system comprising:
a container configured to contain biopharmaceutical materials therein;
a holder having a cavity, said container received in said cavity;
said holder comprising a first portion and a second portion forming an interior cradle, said container received between said first portion and said second portion to connect said container to said holder;
said first portion having a first bottom and first edges extending from said first bottom and forming a first inner rim, said first bottom and said first edges bounding said cavity, said inner rim extending completely around a perimeter of said container, said first inner rim comprising longitudinal sides, ends, and curved corners surrounding said perimeter, each of said corners connecting a longitudinal side of said longitudinal sides to an end of said ends, said container contacting said first bottom, said first edges, and at least one corner of said corners;
said first edges comprising curved surfaces having first edge axes about perpendicular to axes of said curved corners;
said second portion comprising a second bottom bounding said cavity opposite said first bottom and second edges extending from said second bottom and bounding said cavity, said second edges comprising second curved surfaces having second edge axes about perpendicular to said axes of said curved corners, said container contacting said second bottom and said second edges;
said first portion comprising an outer rim connected to said cradle and separated from said cavity and said inner rim; and
wherein said first bottom comprises an inner surface facing said cavity receiving said container and an outer surface, said outer surface of said first bottom being recessed towards said container relative to an outermost surface of said outer rim such that said outermost surface is located further away from said second portion than said outer surface of said bottom is located away from said second portion.

2. The system of claim 1 wherein each of said first curved surfaces and each of said second curved surfaces opposite each other about said cavity having a common axis or a parallel axis relative to each other.

3. The system of claim 1 wherein said inner rim is configured to hold said container in said cradle and to allow said container to move from outside the cradle into the cradle in response to biopharmaceutical material being inserted into said container.

4. The system of claim 3 wherein said second portion comprises a second inner rim and said second inner rim comprises a second substantially flat holder portion configured to engage said inner rim to hold said container and to allow said container to move from outside said cradle into said cradle in response to biopharmaceutical material being inserted into said container.

5. The system of claim 1 further comprising a support rib protruding from an outer surface of said cradle, said rib structurally supporting said cradle to substantially maintain a shape of said cradle in response to an expansion of biopharmaceutical material held in said container due to freezing.

6. The system of claim 5 wherein said support rib extends from a side of said cradle to an opposite side of said cradle.

7. The system of claim 1 wherein said biopharmaceutical materials comprise liquid biopharmaceutical materials.

8. The system of claim 1 wherein said first portion comprises a first inner rim and said second portion comprises a second inner rim, said first inner rim comprising a first plurality of teeth and said second inner rim comprising a second plurality of teeth, said first plurality of teeth and said second plurality of teeth engageable with each other to connect said first inner rim to said second inner rim.

9. The system of claim 1 wherein said second portion comprises a second outer rim separated from said cavity.

10. The system of claim 9 further comprising at least one conduit extending from said container through at least a second cavity to an exterior of said holder, said at least one conduit providing communication between said container and the exterior of said holder.

11. The system of claim 9 wherein a protective cavity is bounded by said outer rim and said second outer rim.

12. The system of claim 1 wherein said outer rim comprises a first plurality of outer teeth engageable with a second plurality of outer teeth of a second outer rim of a second holder to inhibit movement between said holder and the second holder.

13. The system of claim 9 wherein said outer surface of said bottom is recessed toward said cradle relative to said outer surface of said outer rim by an amount dimensioned to allow for expansion of biopharmaceutical materials such that said outer surface avoids extending beyond said outer rim.

14. A system for use in freezing, storing and thawing biopharmaceutical materials, said system comprising:
a container configured to contain biopharmaceutical materials therein;
a holder having a cradle bounding a cavity, said container received in said cavity;
said holder comprising a first portion and a second portion forming said cradle, said container received between said first portion and said second portion to connect said container to said holder; and
a support member protruding from an outer surface of said cradle, said member structurally supporting said cradle and inhibiting deformation of said cradle in response to an expansion of biopharmaceutical material held in said container due to freezing;
said support member having opposite ends thereof directly connected to a first portion of an outer rim and a second portion of said outer rim, said outer rim connected to said cradle and extending around a perimeter of said cradle, said first portion and said second portion located on opposite sides of said holder relative to each other along said perimeter.

15. The system of claim 14 wherein said cradle comprises an outer cradle surface, said outer cradle surface being recessed toward said container relative to an outermost surface of said outer rim such that said outermost surface is located further from said second portion than said outer cradle surface is located from said second portion.

16. The system of claim 14 wherein said cradle comprises a bottom having an inner surface facing said cavity receiving said container and opposite said outer surface, said cradle comprising a groove in said inner surface corresponding to said support member protruding from said outer surface.

17. A system for use in freezing, storing and thawing biopharmaceutical materials, said system comprising:
a container configured to contain biopharmaceutical materials therein;
a holder having a cavity, said container received in said cavity;
said holder comprising a first portion and a second portion, said container received between said first portion and said second portion to connect said container to said holder;
said first portion comprising a first bottom bounding said cavity and said second portion comprising a second bottom bounding said cavity, said first bottom and said second bottom opposite said cavity relative to each other and moveable apart from each other in response to the biopharmaceutical material within said container and said cavity freezing and expanding;
wherein the first bottom and the second bottom are configured to move away from each other due to the freezing such that outer surfaces of the first bottom and the second bottom do not extend beyond an outer rim of the hol

Assignees

• Cutting Jonathan
• Gay Isabelle
• Lee Eric K
• Voute Nicolas
• Sartorius Stedim North America Inc

Inventors

• Cutting Jonathan
• Gay Isabelle
• Lee Eric K
• Voute Nicolas

Classifications

• A01N1/146

  Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving · CPC title

• A01N1/10 Primary

  Preservation of living parts · CPC title

• A01N1/02

  Human Necessities · mapped topic

• Y10T29/53443

  Means to assemble or disassemble container and fluid component · CPC title

• A01N1/0263 Primary

  Human Necessities · mapped topic