Regulatory flexibility can make continuous improvement possible.
Jennifer Mercer
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Jennifer Mercer is the director of regulatory affairs, CMC, at Amgen Inc.
Articles by Jennifer Mercer
Second in a three-part series that discusses the complexities of QbD implementation in biotech development.
First in a three-part series that discusses the complexities of QbD implementation in biotech product development.
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Quality by Design for Biotechnology Products—Part 3January 1st 2010
Quality by Design for Biotechnology Products—Part 2December 1st 2009
Quality by Design for Biotechnology Products—Part 1November 1st 2009
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