risk assessment - Bioprocess Development Forum

Articles BioPharma

April 19, 2017

Critical Quality Attributes Challenge Biologics Development

Critical quality attributes (CQAs) are used in biopharmaceutical development to gain an...

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Articles BioPharma BioPharma Q&A Regulatory Regulatory

July 15, 2015

Risk Assessment and Mitigation in Biopharmaceutical Manufacturing

BioPharm International spoke with Stephan Krause, director of quality assurance, Laura Jeannel...

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Articles BioPharma Regulatory

July 18, 2014

Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products

A critical quality attribute (CQA) has been defined as “a physical, chemical, biological...

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