All biologics production processes focus on preventing adventitious microorganisms from entering upstream processes. Regulatory guidance for upstream processes focuses on comprehensive testing and characterization of raw materials. While there is no specific mandate for implementing viral clearance technologies, manufacturers are increasingly implementing practices that mitigate the risk of contamination and the consequent disruption to manufacturing operations. This webinar will discuss the potential sources of viral contaminants, the strengths and limitations of different detection and removal technologies and explain how they can be integrated into a comprehensive, holistic, upstream viral safety strategy.
Senior Product Manager
Craig has over 20 years of experience in the biotech industry and has always worked directly with biopharmaceutical manufacturers. His breadth of experience includes lab scale process development, commercial process troubleshooting and optimization, new product introductions to the market place, and commissioning of new manufacturing plants. His current role encompasses virus risk reduction in all areas of the biomanufacturing process, with a focus on upstream virus risk mitigation. Craig has a BS in Chemical Engineering from the University of Massachusetts at Amherst.