Stefanie Pluschkell

Stefanie Pluschkell is an associate research fellow in global CMC, biologics and devices, at Pfizer Inc.

Articles

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.