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Process performance Qualifications (PPQ) for cell-based products
Автор: Advbiols
Загружено: 2020-10-14
Просмотров: 1832
Описание: Before market approval, it is necessary to complete process validation of the commercial process. This can only be undertaken if sufficient process knowledge has been accrued to build on earlier process qualification activities to develop a suitable validation approach. This talk will explore some of the challenges with validation of manufacturing processes for cell-based medicines, and consider the various approaches that can be taken.
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