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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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
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Abstract 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.
AbstractList 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.
Author O'Leary, Rhona
Low, Duncan
Pujar, Narahari
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Snippet Technical alternatives to the standard platform approach for antibody purification are certainly emerging, but the reluctance of manufacturers to adopt them is...
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SubjectTerms antibody purification
Biotechnology
changing regulatory environment
CHEMISTRY
economic drivers
follow‐on biologics
technology drivers
therapeutic modality
Title ANTIBODY PURIFICATION: DRIVERS OF CHANGE
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