Stefanie Pluschkell is an associate research fellow in global CMC, biologics and devices, at Pfizer Inc.
Quality by Design for Biotechnology Products—Part 3
Regulatory flexibility can make continuous improvement possible.
Quality by Design for Biotechnology Products—Part 2
Second in a three-part series that discusses the complexities of QbD implementation in biotech development.
Quality by Design for Biotechnology Products—Part 1
First in a three-part series that discusses the complexities of QbD implementation in biotech product development.