Biosafety Considerations for Regulatory Approval of Vaccines and Biologics

Objective

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's Glasgow laboratory is a GMP approved testing facility offering a range of validated methods to test a wide range of cell banks and viral vaccine seeds.

Agenda

• 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
• Q&A

Background

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

This webinar is aimed at all biosafety professionals and vaccine manufactures.

Speaker

Margaret Temple - SGS Business Development Manager

With 25 years experience of client consultation to discuss and recommend biosafety testing strategies to clients in Asia, North America and Europe, Margaret has worked with clients developing a wide range of biologics: vaccines, cell therapies, gene therapies, recombinant proteins and monoclonal antibodies. Margaret started her career with Q-One Biotech in 1995 and was a co-founder of Vitrology (now SGS since its acquisition in 2012) with colleagues who remain in the senior management team at our Glasgow facility.

For more information, please contact:

Josée Leach
Global Marketing Manager - Life Sciences, SGS
m: +44 7889 939 512