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Continuous processing methods for biological products

a technology of biological products and processing methods, applied in the field of continuous processing technology for the production of biopharmaceutical and biological products, can solve the problems of inherently inefficient batch processing techniques, equipment designs for disposable downstream processing, and processing of cultures, and achieve the effect of increasing manufacturing productivity and efficiency

Inactive Publication Date: 2013-10-03
SARTORIUS STEDIM CHROMATOGRAPHY SYST LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention introduces a novel continuous processing technology (CPT) for the purification of biopharmaceuticals. This technology allows for an entire purification process to be operated continuously using disposable processing elements, which increases manufacturing productivity and efficiency in the biopharmaceutical industry.

Problems solved by technology

Until recently, the majority of biopharmaceutical and biological products have been manufactured and purified at very modest scale, obviating the need for moving away from inherently inefficient batch processing techniques.
However, as the capacity of industrial scale disposable bioreactors has leapt forward, the equipment designs for disposable downstream processing (that is, processing of the culture grown in a bioreactor to end in a final packaged product) have lagged behind.
For example, while new bioreactors capable of 2,000 liter cell cultures are now on the market and 5,000 liter capacity disposable bioreactors are being designed, the largest disposable downstream chromatography columns currently available are not large enough (ca.

Method used

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  • Continuous processing methods for biological products
  • Continuous processing methods for biological products

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Embodiment Construction

[0085]The present invention provides processes that can be adapted to the manufacture of a biological product which make at least two or more steps of the processing of the biological product continuous. Continuous processing allows the manufacturer to conduct the manufacturing process using less material and relying on equipment of a reduced scaled compared to the equipment that would be required for batch operations. Continuous processing reduces downtime in the overall manufacturing process and thus reduces cycle times from the beginning of a manufacturing run to production of bulk drug substance or packaging of the final product.

[0086]In order that the invention may be more clearly understood, the following abbreviations and terms are used as defined below.

[0087]The term “biological product” as used herein refers to a product of interest created via biological processes or via the chemical or catalytic modification of an existing biological product. Biological processes include ...

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Abstract

The present invention is directed to the development of continuous processing technology for the purification of biopharmaceuticals and biological products, such as monoclonal antibodies, protein therapeutics, and vaccines. Methods for continuous processing of a biological product in a feed stream toward formulation of a purified bulk product are described.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims priority to U.S. Provisional Application No. 61 / 420,066 filed Dec. 6, 2010, the entire contents of which are incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention is directed to the development of continuous processing technology for the production of biopharmaceutical and biological products, such as monoclonal antibodies and vaccines.BACKGROUND OF THE INVENTION[0003]Continuous processes are widely used in several industries, for instance the petrochemical, fine chemical, and agricultural processing industries. Distillation, plug flow reactions, chromatography, and adsorptive separations are all operated in continuous modes in large-scale industrial applications. For example, a well known large-scale simulated moving bed (SMB) purification process is the so-called Parex process, which separates para-xylene from a mixture of xylenes. This process is based on the Sorbex SMB technology dev...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C12P21/00
CPCC12M47/10C12M47/12C07K1/36C07K16/00C12P21/00B01D15/1821B01D15/3804C07K1/16C12Q1/24C12M1/12C12M23/44G01N30/02
Inventor RANSOHOFF, THOMAS C.BISSCHOPS, MARC A. T.
Owner SARTORIUS STEDIM CHROMATOGRAPHY SYST LTD
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