Qualification of Scale-Down Bioreactors

摘要

Validation of Process Changes in Commercial Production of Animal-Cell-Derived Products, Part 2 — Application. Here we apply our approach to validation of animal cell culture process changes using qualified, scale-down bioreactors. As described in Part 1 (including Table 1, Figures 1 and 2, and References 1-23), the goal is to facilitate implementation for the benefit of both the patients and industry. "Qualification of Scale-Down Bioreactors: Validation of Process Changes in Commercial Production ofAnimal-Cell-Derived Products, Part 1 — Concept" appears on pages 38-45 of BioProcess International's May 2014 issue.