The objective of this webinar (30-minute presentation / 15-minute Q&A) is to explore current testing strategies and validated assay methods to ensure biosafety compliance and outline the application of new methods for example next generation sequencing.
SGS 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.
Sources of potential viral contamination during development and manufacture of vaccines and biologics
Overview of key global regulatory authority guidelines
Current testing strategies for different cell and viral substrates
Overview of compendial and GMP validated assay methods
Vaccines are considered the most effective way to prevent infectious diseases, and during vaccine development and manufacture all vaccines are thoroughly tested to ensure they can be safely administered to the specific target population at large.
A key aspect of vaccine development requires consideration and compliance with the current regulatory authority guidelines for example the US Food and Drug Administration (FDA) Guidance for Industry Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications February 2010 and the European Pharmacopoeia sections 5.2.3 and 2.6.16. The regulatory authorities are very focussed on potential sources of contamination of biological substrates and in-process materials as vaccine development is frequently limited with regard to the possibility of introducing purification steps.
Target Audience: The webinar is aimed at all biosafety professionals and vaccine manufactures
Language: English Cost: No Charge
Can't make a live session? Register now and receive a complimentary recording after the live event.