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Catalent Expert to Present on Viral Safety of Biopharmaceuticals

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:
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