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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
Establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
The author describes techniques that can be used to provide the analytical data required by ICH Q6B for characterization of monoclonal antibodies.