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Biopharmaceutical Manufacturing Process Validation and Quality Risk Management

By: F. Castillo, et al

Reprinted with the permission of Pharmaceutical Engineering, May-June, 2016
Manufacturing processes for biopharmaceuticals must be designed to produce products that have consistent quality attributes. This entails removing impurities and contaminants that include endotoxins, viruses, cell membranes, nucleic acids, proteins, culture media components, process chemicals, and ligands leached from chromatography media, as well as product modifications, aggregates, and inactive forms.

Manufacturing processes should be validated by applying a scientifically rigorous and well-documented exercise demonstrating that the process, and every piece of equipment used in it, consistently performs as intended, and that the process, when operated within established limits, generates a product that routinely and reliably meets its required quality standards.