ANTIBODY PURIFICATION: DRIVERS OF CHANGE

• Published in: Process Scale Purification of Antibodies pp. 699 - 716
• Main Authors: Pujar, Narahari, Low, Duncan, O'Leary, Rhona
• Format: Book Chapter
• Language: English
• 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
• DOI: 10.1002/9781119126942.ch32
• ISBN: 9781119126911; 1119126916

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.