Catalent Expert Presents the Requirements and Importance of Viral Safety for Biologicals
Somerset, NJ, May 9, 2011
– Catalent scientist and manager of Viral Clearance and Safety, Hazel Aranha, Ph.D., will have a prominent role in leading this year’s Viral Safety for Biologicals workshop held at the Angelo Hotel in Prague, Czech Republic on May 10-11, 2011. Sponsored by Informa Life Sciences, the annual workshop will provide attendees the ability to meet evolving regulatory requirements by learning the latest detection methods and how to react effectively when faced with the risk of viral contamination.
At the pre-conference workshop held on Monday, May 9, Dr. Aranha will present, “Ensuring Viral Safety of Biopharmaceuticals: Risk Assessment and Regulatory Considerations as Applied to Marketed Products and Investigational Medicinal Products (IMPs).” Dr. Aranha’s workshop will highlight regulatory requirements and facilitate understanding as well as appreciation for the philosophies that underlie these regulations. Additionally, she’ll provide a toolkit to attendees to help evaluate viral clearance methods and design virus clearance evaluation (validation) studies.
On Tuesday, May 10, Dr. Aranha will discuss pragmatic approaches to ensuring virological safety of biologicals with attendees in a presentation entitled “Déjà Vu: What’s Old is New Again, Half a Century Later - Experience in Ensuring Virological Safety of Biologicals.” Recent contamination incidents have once again focused the spotlight on virus contamination during the manufacture of biologicals. Dr. Aranha will highlight issues relating to the detection of virus sequences in marketed products that have the potential to compromise patient safety. Additionally, the presentation will look at the contamination of production systems with viruses theoretically non-infective for humans adversely impacting product yield and market availability.
In addition to her current position with Catalent, Dr. Aranha serves 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 is credited with two books, more than 45 publications, and four book chapters. Dr. Aranha has a Master’s degree in Virology, Ph.D. in Environmental Microbiology and holds Regulatory Affairs Certification (RAC) for the US and European Union.
To download a copy of Dr. Aranha’s presentation after the event, visit www.catalent.com .
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 approximately 8,000 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.