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Separative harvesting device

a harvesting device and separation technology, applied in lighting and heating apparatus, ventilation systems, heating types, etc., can solve the problems of difficult to use these steps, use very large-scale filtration and volume reduction methods that cost millions of dollars to install and millions more to operate and maintain, and achieve the effect of improving the ability to elu

Inactive Publication Date: 2013-06-06
THERAPEUTIC PROTEINS INT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The invention makes use of resins that can bind biological products like drugs, eliminating the need for expensive filtration and volume reduction methods. The resins can be combined to remove any type of biological product from a solution, making the process simpler and more cost-effective. The invention also allows for the separation of biological products from resins and the further purification of the final product. This technology could make it more affordable to produce drugs and make them accessible to billions of people worldwide.

Problems solved by technology

While these process steps have been widely validated and function very well, the practicality of using these steps becomes very difficult when large volumes of medium is handled.
To accommodate this, companies use very large-scale filtration and volume reduction methods that cost millions of dollars to install and millions more to operate and maintain.

Method used

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first embodiment

[0070]In a first embodiment, the instant invention proposes a bioreactor capable of growing all types of cells and organisms and additionally provides a ready means of harvesting of biological products in a bioreactor. The instant invention employs a mechanical device, which in one step combines several steps or biological product harvesting. The method of the present invention presents a novel procedural step for simultaneously extracting and concentrating a biological product of interest from a host cell, at the same time removing practically all, or at least the majority, of the host cell biological products.

second embodiment

[0071]In a second embodiment, the present invention relates to a bioreactor that contains a resin capable of binding target biological products but kept separate from the culture medium by placing it inside a pouch that has porous walls with pores small enough to hold the resin inside the pouch yet allow the culture media containing target biological product to freely equilibrate with the resin. By placing the resin in a pouch, several arduous steps in protein harvesting are avoided. It is the purpose of this invention to work the purification process in an opposite order to how the art is currently practiced universally. In all instances, upon the completion of the bioreaction, the dirst step is to remove the host cells or organisms by filtration or centrifugation. With the bioreactor volumes into thousands of liters, this process is extremely arduous, expensive and requires additional storage vessels of about the same size as the bioreactor making it difficult to accommodate these...

third embodiment

[0073]In a third embodiment, the instant invention obviates the need for costly cross-flow filtration processes used in every type of manufacturing of biological products as in almost all instances a concentration step is involved to reduce the volume of liquid that is loaded onto purification column. The purification of biological therapeutics generally involves the use of cross flow filtration (tangential flow filtration), normal flow filtration (dead ended filtration) combined with chromatographic separations. Cross flow filtration and normal flow filtration retain matter through size exclusion and are complementary to chromatography's selectivity. For processes where volumes are large such as into thousands of liters, the cost of equipment for filtration is into hundreds of thousands of dollars with expensive filters all adding to a cost that represents a major fraction of the total cost of manufacturing of recombinant drugs.

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PUM

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Abstract

A harvesting device for capturing a biological product directly by binding the secreted biological product with a resin, discarding the nutrient medium and eluting the biological product as a concentrated solution, eliminating the steps of sterile filtration and volume reduction, thus allowing one to combine the steps of recombinant expression and separation of a biological product. The method allows loading of resin for column-purification, eliminating all steps of perfusion process and maintaining a sink condition of a toxic product in nutrient medium to optimize productivity of host cells. The instant invention also allows harvesting of solubilized inclusion bodies after the cells have been lysed and refolding of proteins inside the bioreactor.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application is a continuation of U.S. patent application Ser. No. 13 / 092,955, filed on Apr. 24, 2011, entitled SEPARATIVE BIOREACTOR, the entire contents of which is incorporated herein by reference.FIELD OF INVENTION[0002]The instant invention relates to a bioreactor design intended to capture and purify biological products within the bioreactor.BACKGROUND OF THE INVENTION[0003]The present invention relates to a novel bioreactor design for expressing and separating a biological product from other components in a bioreaction borth, which combines the step of expressing and separating within the bioreactor by binding the biological product with a resin within a bioreactor, discarding the nutrient medium and eluting the biological product as a concentrated solution; this allows elimination at least two steps in the separation and purification of biological products—filtration or centrifugation to remove cell culture and ultrafiltration ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C12M1/00B01F33/40
CPCC12M23/14C12M25/14C12M27/16C12Q3/00C12M41/32C12M47/10C12M29/06Y10T137/0318F24F7/06
Inventor NIAZI, SARFARAZ K.
Owner THERAPEUTIC PROTEINS INT
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