Articles by Andrew J. Reason - BioPharm International

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Articles by Andrew J. Reason

Defining Critical Quality Attributes for mAb Therapeutic Products

An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
Jul 1, 2014

Establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.

Structural Characterization of Monoclonal Antibodies

The author describes techniques that can be used to provide the analytical data required by ICH Q6B for characterization of monoclonal antibodies.
Aug 2, 2011

The author describes techniques that can be used to provide the analytical data required by ICH Q6B for characterization of monoclonal antibodies.

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