Quality-by-Design for Freeze-thaw of Biologies:Concepts and Application During Controlled Freeze and Thaw

摘要

This article, the second of two parts, continues the discussion of the application of Quality-by-Design (QbD) principles to freeze-thaw and storage of biologies drug substances. Specifically, we focus on the application of QbD to cryo-celsius bag systems (up to16.6 L) as well as cryo-vessels (125 to 300-L). Establishment of a disciplined QbD program, and the elements that comprise such an approach, are described.