Quality attributes - Bioprocess Development Forum

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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Articles

March 15, 2014

Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle

With the most recent FDA (1) and Inter-national Conference on Har-monization (ICH) guidances...

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