ANTIBODY PURIFICATION: DRIVERS OF CHANGE

Technical alternatives to the standard platform approach for antibody purification are certainly emerging, but the reluctance of manufacturers to adopt them is a reflection of the conservatism in our industry. This conservatism is driven by two factors—the regulatory burden of making changes and whe...

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Bibliographic Details
Published inProcess Scale Purification of Antibodies pp. 699 - 716
Main Authors Pujar, Narahari, Low, Duncan, O'Leary, Rhona
Format Book Chapter
LanguageEnglish
Published United States John Wiley & Sons, Incorporated 2017
John Wiley & Sons, Inc
Subjects
antibody purification
Biotechnology
changing regulatory environment
CHEMISTRY
economic drivers
follow‐on biologics
technology drivers
therapeutic modality
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Summary:Technical alternatives to the standard platform approach for antibody purification are certainly emerging, but the reluctance of manufacturers to adopt them is a reflection of the conservatism in our industry. This conservatism is driven by two factors—the regulatory burden of making changes and whether a new technology/approach fits within existing facility designs. This chapter focuses on some of the topics that influence change and may facilitate the stepwise incorporation of improvements. These include, but are not limited to, the changing regulatory environment, coupled with the ever‐increasing ability (and requirement) to generate data, the emergence of innovative technology, process economics, the globalization of our industry, and finally follow‐on biologics (FOBs). Ultimately, the continued evolution of antibody purification will be a function of the continued popularity of antibodies as a therapeutic modality.
ISBN:9781119126911
1119126916
DOI:10.1002/9781119126942.ch32