ICH Q5A updates and its Impact on BioProcessing

About the Webinar
Recent advancements in bioprocessing have supported the accelerated growth of the biopharma industry. In response to these advancements, industry forums have focused on the need to minimize pathogen risk during biologics production amid calls for new process design, technologies and detection strategies. The upcoming revision of ICHQ5A will include the use of new technologies and viral clearance strategies to also examine cell, gene therapies and newer vaccine paradigms such as virus like particles, subunit proteins, and viral vectors. This webinar will focus on presenting the impact to industry from these updates.
About Manjula Aysola i
Manjula is a Senior Regulatory Consultant supporting the BioReliance Testing Services business of MilliporeSigma based in Boston, Massachusetts, USA. She is an expert on regulatory requirements for quality of biologics and cell/gene therapeutic products and consults to ensure compliant testing services. Prior to this role she focused on regulatory requirements for single-use systems and raw materials for cell/gene therapy manufacturing. She also spent over 10 years as an R&D scientist involved in developing products for biologics and cell therapy bioprocessing.
Prior to MilliporeSigma she spent over five years working as an R&D scientist in early discovery programs at Millennium Pharmaceuticals. Manjula holds a B.S. in Biology from Osmania University, India, a Masters in Genetics from Clemson University and a certificate in Regulatory Affairs from Regulatory Affairs Professional Society.