Biotherapeutic Drug Product Manufacturing and Process Development

Abstract

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).