Webinar: Control Potential Viral Contaminants in Biologics with Effective Testing
The release of biopharmaceutical drugs into clinical trials or for application as licensed products requires regulatory authority approval of data from appropriate tests to ensure products are free from potential adventitious agent contamination.
May 6, 2020, 12:30
May 6, 2020, 13:30
Historical incidents, when patients with haemophilia and blood-related conditions were infected with HIV and other blood-borne viruses after being given treatment using proteins isolated from human plasma, are well documented.
This resulted in the establishment of clearly defined testing strategies and methods to ensure known and potential unknown contaminating adventitious agents can be detected in biopharmaceutical products.
The objective of this webinar (30-minute presentation/15-minute Q&A) is to outline current testing strategies for a range of biological substrates and focus on the types of validated assay methods required to ensure detection of potential adventitious agents.
Differences in approved assay methods, such as cultivation methods and marker methods, will be presented. The SGS biosafety testing laboratory in Glasgow is a GMP approved testing facility offering a range of validated methods to test a wide range of cell banks and viral vaccine seeds.
The webinar will cover:
- Types of biological material requiring testing
- Potential sources of viral contamination
- Historical product contaminations reported to the global regulatory authorities
- Expectations of the global regulatory authorities
- The application of a range of infectivity and marker-based test methods for virus detection
- The importance of GMP assay validation
The webinar is aimed at all pharmaceutical and biopharmaceutical professionals
Cost: No Charge
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