Articles by Joseph Mezzatesta - BioPharm International

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Articles by Joseph Mezzatesta

Quality by Design for Biotechnology Products—Part 3

Guidance from the Quality by Design Working Group of the PhRMA Biologics and Biotechnology Leadership Committee on how to apply ICH Q8, Q8R1, Q9, and Q10 to biopharmaceuticals.
Jan 1, 2010

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.
Dec 1, 2009

Second in a three-part series that discusses the complexities of QbD implementation in biotech development.

Quality by Design for Biotechnology Products—Part 1

A PhRMA Working Group's advice on applying QbD to biotech.
Nov 1, 2009

First in a three-part series that discusses the complexities of QbD implementation in biotech product development.

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