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 on the industry from these updates.
In this webinar, we'll share:
- Acceptance of innovative technologies in biologics testing
- Impact of ICHQ5A (R2) on therapy development and manufacturing
- Advice from PDA and industry forums
- Updated approaches to viral clearance
Speakers
Manjula Aysola, Ph.D.
MilliporeSigma
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.
Kathryn Martin Remington, Ph.D.
MilliporeSigma
Technical Consultant
Kathryn Martin Remington, Ph.D. is a member of the field technology management group and provides U.S. clients with technical and regulatory support. Kathy joined the organization in 2010 from Catalent Pharma Solutions where she established a viral clearance program. She was also the section head of the viral validation group for Bayer Healthcare. During her nearly 20 years in viral clearance, she has authored a number of publications on the viral safety of biopharmaceuticals. Kathy earned her M.S. and Ph.D. degrees in microbiology from the University of Montana.
Pharma and biopharma manufacturing
- Biologics and Biosimilars Characterization
Duration:30min
Language:English
Session 1:presented August 26, 2021
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