Biotherapeutic Drug Product Manufacturing and Process Development

  • Daniel DixonEmail author
  • Anthony Gudinas
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 38)


This chapter describes a typical biologics drug product manufacturing process and typical work to support that process. Unit operations addressed include dilution strategies and mixing, sterile filtration, filling, capping, and inspection, with a separate discussion on hold time monitoring. As each unit operation is discussed, manufacturing considerations and typical laboratory study designs are also introduced. A knowledge-based process design feeds into a robust risk management program, which in turn supports the Quality by Design paradigm. As a program progresses to later stages, the focus of the Quality by Design paradigm becomes demonstrating control of the process (through the control strategy) and proving consistency (through Process Performance Qualification).


Drug substance dilution Sterile filtration Filling Hold times Quality by Design 


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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  1. 1.BioTherapeutics Pharmaceutical Sciences, Pharmaceutical R&DAndoverUSA

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