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Autor:
Fiona Madden, Kevin Clark, Marta C. Abad, Jingjie Mo, Caitlin O'Mahony Hartnett, Nikky Le, Barry McCarthy, Jim O'Mahony, Luke A. Gibbons, Francis Maslanka, Christopher Rode, Rosemary Rea, Kerry Robinson, Carl Rafferty, Ronan Hayes
Publikováno v:
Biotechnology Progress. 38
The Quality by Design (QbD) approach to the production of therapeutic monoclonal antibodies (mAbs) emphasizes an understanding of the production process ensuring product quality is maintained throughout. Current methods for measuring Critical Quality