Maximizing quality in the manufacture of biologicals

Author(s): Gustavo Grampp, PhD, Sundar Ramanan, PhD

Abstract: Biological product quality is susceptible to unexpected manufacturing issues, and the resulting variation may impact the safety or efficacy of these medicines and increase risks to patients. These risks can be managed more effectively by manufacturers’ adoption of the culture and practices of high reliability organizations and by their sharing of quality risk management […]

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