Stirred-tank reactor system

Inactive Publication Date: 2005-10-27
BAXALTA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0008] The present invention provides a stirred-tank reactor system with disposable elements, such as a flexible plastic bag with an attached bearing, shaft, and impeller assembly. The instant invention further relates to the use of this novel stirred-tank reactor system as a disposable bioreactor and in kits with disposable elements. The advantages of the present invention are numerous. Particularly, the stirred-tank reactor system may be pre-sterilized and does not require a steam-in-place (SIP) or clean-in-place (CIP) environment for changing from batch to batch or product to product in a culture or production system. As such, the system requires less regul

Problems solved by technology

Consequently, the production of products in aseptic bioreactors is costly which provides the motivation for pursuing improved systems.
The various disadvantages of such bioreactors include heterogeneous cell mass, difficult procurement of representative cell growth samples, poor performance due to inefficient oxygenation and an inability to control oxygen levels, and problems with contamination of cell cultures.
Moreover, micro-environmental factors such as pH cannot be effectively controlled and a mixed culture or co-culture of cells is not possible.
However, occasional contamination of cell cultures and an inability to control pH levels effectively remain consistent problems.
The expense of producing cells, biopharmaceuticals, biologicals and the like in aseptic bioreactors is exacerbated by the r

Method used

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a) Definitions and General Parameters

[0018] The following definitions are set forth to illustrate and define the meaning and scope of the various terms used to describe the invention herein.

[0019] The term “flexible bag” refers to a container that holds a fluidic medium. The bag may include one or more layer(s) of flexible or semi-flexible waterproof material depending on size, strength and volume requirements. The inside surface of the bag is preferably smooth and provides a sterile environment (e.g., for culturing cells or other organism, for food production, etc.). The bag may include one or more openings, pouches (e.g., for inserting one or more probes, devices, etc.), ports (e.g., for the connection of one or more probes, devices, etc.) or the like. Furthermore, the bag provides a disposable alternative to a solid vessel in a conventional stirred-tank bioreactor. The flexible bag may further include a shaft, an impeller, a bearing and seals or o-rings, and may be entirely di...

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Abstract

The present invention relates to a stirred-tank reactor system and methods of preparing such systems. The present invention further encompasses the use of the stirred-tank reactor system as a disposable bioreactor and in kits with disposable elements.

Description

FIELD OF THE INVENTION [0001] The present invention relates to a stirred-tank reactor system and methods of preparing such systems. The present invention further encompasses the use of the stirred-tank reactor system as a disposable bioreactor and in kits with disposable elements. BACKGROUND OF THE INVENTION [0002] A bioreactor or fermenter is a container used for fermentation, enzymatic reactions, cell culture, biologicals, chemicals, biopharmaceuticals, tissue engineering, microorganisms, plant metabolites, food production and the like. Bioreactors vary in size from benchtop fermenters to stand-alone units of various sizes. The stringent asepsis requirements for sterile production in bioreactors usually requires elaborate systems to achieve the desired product volumes. Consequently, the production of products in aseptic bioreactors is costly which provides the motivation for pursuing improved systems. [0003] Conventional bioreactors perfuse nutrient media through a single type of ...

Claims

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Application Information

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IPC IPC(8): C12M1/00C12M1/02C12M1/04C12M1/12
CPCB01F7/001B01F7/1695B01F7/22B01F15/00006B01F15/00831Y10T29/49826B01F2215/0073C12M23/14C12M27/02C12M29/06B01F15/0085C12M23/00C12M23/06C12M23/26C12M23/28
Inventor KUNAS, KURT T.OAKLEY, ROBERT V.
Owner BAXALTA INC
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