Hazel Aranha, PhD, RAC, Sartorius Stedim Biotech, Bohemia, NY
Viral safety is a critical quality attribute (CQA) in bio-pharmaceutical manufacturing operations. The viral risk profile of any biological is contingent on a variety of factors including: source of the biological, production systems, and raw materials/purification reagents/excipients used. While the current safety tripod - appropriate sourcing, demonstrating viral clearance capacity of the manufacturing process, and in-process controls - has delivered bio-pharmaceutical products with an excellent safety profile (from a virological safety standpoint) we will continue to be vulnerable to new and emerging viruses.
Zero risk is a myth. Clinical acceptability of biologicals must, of necessity, be guided by a risk-based approach. Risk assessment, mitigation and management are essential components of virus safety assurance. This presentation will address current pragmatic approaches to ensuring virological safety of biologics including risk evaluation and application of risk assessment tools. Regulatory approaches and industry best practices will also be discussed.
Hazel Aranha is a bio-pharmaceutical industry professional with over 30 years’ experience in industry, academia and consulting. She has provided consulting services in the US, Europe and Asia. She teaches courses on ‘ensuring virus safety of biologicals’, as well as other topics including: ‘Good Clinical Practices’ (GCP), ‘Good Manufacturing Practices (GMP), ‘Downstream Processing’, ‘Navigating the Drug Development Cycle’, and ‘Effective Biomedical Writing’.
Hazel has a Master’s degree in Virology, Ph.D. in Environmental Microbiology and holds Regulatory Affairs Certification (RAC) for both the US and European Union. She has to her credit 2 books, over 45 publications, and 5 book chapters. Her past assignments have included positions at Catalent Pharma Solutions, Wyeth Vaccines (Pfizer), and Pall Corporation.