Catalent Expert To Present On Viral Safety of Biopharmaceuticals At The 2011 Massachusetts Biotechnology Council
Somerset, NJ – September 8, 2011 – Hazel Aranha, PhD, RAC, Manager, Viral Clearance and Safety, at Catalent Pharma Solutions will present at the Massachusetts Biotechnology Council (Formulation and Drug Delivery Committee) meeting in Cambridge, MA. Dr. Aranha’s presentation, “Viral Clearance Strategies for Biopharmaceutical Safety” will take place on Friday, September 16, 2011 from 12:00 noon to 2:00 pm.
Attendees will gain insights into the unique challenges associated with ensuring virological safety, the importance of pre- and post-production controls and incorporation of a Quality-by-Design approach, and their impact on the safety profile of biopharmaceuticals. This timely presentation follows the recent reports of adventitious virus contamination of products and production environments and accentuates the necessity of a holistic approach to virus safety.
Other key topics will include:
- Design and implementation of an appropriate and relevant virus clearance strategy that includes the use of specific and non-specific model viruses to address threats posed by existing and emerging viruses
- Requirements and practical considerations in designing virus clearance evaluation (validation) studies for marketed products as well as investigational medicinal products
- Relevance and importance of leveraging data from platform technologies and design-of-experiment studies
For more information on this event, please visit: www.massbio.org .
Dr. Aranha has over 30 years experience in academia, industry and consulting. She has a Masters in Virology, PhD in Environmental Microbiology and holds Regulatory Affairs Certification (RAC) for the US and European Union. She is a well-acknowledged expert in the area of virus and prion clearance from biopharmaceuticals. She has provided consulting services in the US, Europe and Asia. She is on several advisory boards of government/semi-government bodies and on the editorial board of BioProcess International Journal. In addition to courses on virus and prion safety of biologicals, she teaches courses on ‘Good Clinical Practices’ (GCP), ‘Good Manufacturing Practices (GMP), ‘Downstream Processing’, ‘Navigating the Drug Development Cycle’, and ‘Effective Biomedical Writing’.
Dr. Aranha was honored as one of the ‘Women in Biotech in the Twenty-First Century’. She has to her credit 2 books, over 45 publications, and 4 book chapters. Her previous assignments include Wyeth Vaccines and Pall Corporation.
From drug and biologic development services to delivery technologies to supply solutions, Catalent Pharma Solutions has the deepest expertise, the broadest offerings and the most unique technologies in the industry. With over 75 years of experience, Catalent helps customers get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging solutions. Catalent employs more than 8,200 people at 24 facilities worldwide and in fiscal year 2010 generated more than $1.7 billion in annual revenue. Catalent is headquartered in Somerset, NJ.