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Leveraging 3Rs for Superior Cell Line Characterization



WEBINAR

In this webinar, you’ll learn:

  • How the regulatory landscape is evolving to support sustainable approaches with respect to 3Rs in biosafety testing
  • How a roadmap can be employed to drive replacement, reduction and refinement of the use of animals in quality control testing
  • About recently published data supporting the use of Next Generation Sequencing for replacing in vivo testing for adventitious virus detection
  • How the introduction of sustainable, alternative methods can help to drive reduced timelines for cell line characterization

With many technological advances in biologics safety testing, non-animal alternatives to classical animal tests have been developed, providing a foundation for a growing number of regulatory changes, which in turn provide a supportive framework for a 3Rs (replace, reduce, refine) approach in biologics safety testing.

In this webinar, we review the regulatory landscape and explore an approach to developing 3Rs roadmaps. We present recently published data demonstrating the value of next generation sequencing (NGS) as a replacement for in vivo testing for adventitious viruses, and discuss implementing the latest technologies, including NGS, in a faster cell line characterization package.

Speaker List

Anna Woodward, Ph.D.

Anna Woodward, Ph.D.

Merck

Technical Consultant

Anna Woodward joined the organization in 2019 and has 20 years’ experience providing technical support to developers and manufacturers of small molecules and biologics. In her current role as a Technical Consultant, Anna supports the BioReliance® services portfolio and works closely with clients and internal colleagues to provide scientific and regulatory guidance on biosafety testing packages. Anna holds a PhD in cell biology from the University of Dundee, Scotland.

Sarah Sheridan, Ph.D.

Sarah Sheridan, Ph.D.

Merck

Senior Technical Consultant

Dr Sarah Sheridan, Senior Technical Consultant at our company, provides scientific, technical and regulatory consultancy within the BioReliance® Biosafety Testing business. Drawing on over 30 years of experience in the biotech industry, Dr Sheridan provides biosafety testing consultancy for the company’s global client base to support pre-clinical to commercial phase biosafety testing of client manufactured products spanning monoclonal antibodies to vaccines and novel gene therapies. Dr Sheridan has a Ph.D. in Veterinary Virology from the University of Cambridge, UK and a B.Sc. Honours degree in Life Science.

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