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Integrated continuous isolation of fluid streams from sterile process vessels

A container, fluid technology, applied in the field of integrated continuous separation of fluid flow from sterilization processing containers, which can solve the problems of not eliminating risks, cost hindering continuous process, taking a lot of time to operate and sterilize containers, etc.

Active Publication Date: 2017-08-29
GENZYME CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

But this is not ideal as it is a batch process (not continuous) and takes a lot of time to manipulate and sterilize the containers
These operations also create a risk to the process if any step fails
Alternatively, the same process can be done using pre-sterilized bags, however the cost of the bags may prevent a continuous process and the use of bags does not eliminate the risk in the process

Method used

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  • Integrated continuous isolation of fluid streams from sterile process vessels
  • Integrated continuous isolation of fluid streams from sterile process vessels

Examples

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Embodiment 1

[0099] figure 2 An exemplary system for separating a sterile process stream from a non-sterile environment according to the present invention is described. The system can be a component of any aseptic process including, for example, a biomanufacturing process flow. like figure 2 As shown in , the system includes a sterile process container (110) (eg, a first container) that includes a fluid outlet (130). For a biomanufacturing process stream, the first vessel can be, for example, a fluid conduit for flowing a liquid medium, a bioreactor (e.g., any exemplary bioreactor described herein or known in the art), a chromatographic One or more components of a system (eg, a chromatography column), one or more components of a microfiltration system, one or more components of an ultrafiltration / diafiltration system. figure 2 The system described in further comprises a separation vessel (120) (e.g., a second vessel) comprising and configured to be in fluid communication with the flu...

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Abstract

Provided herein are isolation processes and the associated hardware to allow fluid streams to be isolated from a sterilized system (e.g., a sterile process vessel) that contains a sterile process. The isolation processes described herein allow for continuous removal of fluid streams (e.g., waste streams, liquid containing recombinant therapeutic proteins) from a sterilized system (e.g., a biological manufacturing system), which provides for less manual manipulation of the sterilized system and a decreased risk of contaminating the sterilized system.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Patent Application Serial No. 62 / 068,181, filed October 24, 2014, the entire contents of which are hereby incorporated by reference. technical field [0003] The present invention relates to biotechnology and biomanufacturing methods of recombinant proteins. Background of the invention [0004] Mammalian cells containing nucleic acids encoding recombinant proteins are routinely used for the production of therapeutically or commercially important proteins. In the current environment of diverse product lines, biotechnology companies are increasingly driven to develop innovative solutions for the highly flexible and cost-effective manufacture of therapeutic agents (eg, therapeutic protein drug substances). [0005] In continuous biomanufacturing processes it is often necessary to remove fluids from sterile process vessels. This fluid removal can be continuous flow or in...

Claims

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Application Information

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IPC IPC(8): C12M1/00C12M1/12C12M1/26C12P21/00
CPCC12M23/58C12M29/04C12M29/10C12M29/26C12M33/04C12M37/00C12M37/02C12M37/06C12P21/00C12M1/00C12M1/12C12M1/26
Inventor R·斯诺
Owner GENZYME CORP
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