Running a biopharmaceutical business involves ever-present risk. Financial, scientific, and patient risks present themselves at every turn. Why introduce yet more risk in the manufacturing suite, where you can arguably least afford it?
While manufacturing standards and regulatory interaction provide risk management guiderails, there remains plenty of margin for error in the production of biologic therapies. In recent years, however, the biopharma industry has developed dozens of constructs to help manufacturers consider, plan for, and ultimately mitigate opportunities for risk in the manufacturing process.
This e-book offers a collection of fresh insights from biopharma risk mitigation experts Peter H. Calcott, Ph.D. (Calcott Consulting LLC), James Vesper, Ph.D., MPH (ValSource, LLC), Ajay Pazhayattil (Capcium Inc.) and Emergent BioSolutions' Praveen Joseph and Ciona Forsythe. From setting up and implementing a QRM program to objectively measuring your risk appetite and risk tolerances to proving sound risk management through factory and site acceptance testing (FAT and SAT), the wisdom of these experts will help guide your risk management strategy.