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Identification and prevention of antibody disulfide bond reduction during cell culture manufacturing

22 Feb 2010

Abstract excerpt

In the biopharmaceutical industry, therapeutic monoclonal antibodies are primarily produced in mammalian cell culture systems. During the scale-up of a monoclonal antibody production process, we observed excessive mechanical cell shear as well as significant reduction of the antibody's interchain disulfide bonds during harvest operations. This antibody reduction event was catastrophic as the product failed to...

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PMID: 20178122
DOI: 10.1002/bit.22699

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