PRODUCT QUALITY ATTRIBUTE CONTROL


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PRODUCT QUALITY ATTRIBUTE CONTROL
PRODUCT QUALITY ATTRIBUTE CONTROL
INTRODUCTION This section focuses on the implementation of product quality attribute control (PQAC) for biopharmaceutical product manufacturing. PQAC of these products is mainly concerned with controlling aspects of the product that may impact the function of the product, such as patient outcomes. The majority of the discussion is focused on the upstream portion of the manufacturing process. Process perturbations and environmental conditions at this stage, where the macromolecules are actually created in the host cells, can have the greatest impact on critical product quality attributes (CPQAs). Appli…
Citation
Dr. Don W. Green; Dr. Marylee Z. Southard: Perry's Chemical Engineers' Handbook, 9th Edition. PRODUCT QUALITY ATTRIBUTE CONTROL, Chapter (McGraw-Hill Professional, 2019), AccessEngineering Export