Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination, making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline, outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements, including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples.
In this webinar, you will learn:
Alison Armstrong, Ph.D.
Sr. Director, Technical and Scientific Solutions
Alison Armstrong is the global head of the field technology management team. She was appointed senior director, UK development services in 2009, and established a client-facing technology management team in 2015. This team is responsible for scientific and regulatory advice and fully supports clients. Alison has authored several articles on trends in biosafety testing and is a member of regulatory taskforce groups related to rapid technologies. She is an invited speaker at global conferences. She holds a Ph.D. in molecular virology from the University of Glasgow.
Manjula Aysola, Ph.D.
Senior Regulatory Consultant
Manjula Aysola is a senior regulatory consultant in the global regulatory management team. She is an expert on regulatory requirements for quality control of biopharmaceuticals including cell and gene therapies, and she has expertise in regulatory expectations for single-use manufacturing systems and cell/gene therapies manufacturing. With MilliporeSigma for more than 16 years, Manjula led several R&D projects for bioreactor process development and cell culture media evaluations for stem cell therapies with the organization.
She was previously with Millennium Pharmaceuticals, focused on oncology target and biomarker discovery. Manjula earned her M.S. degree in genetics from Clemson University.