Does PUPSIT Reduce Risk for Sterile Filtration?

Dr. Janmeet Anant, PMP, RAC, is a Senior Regulatory Consultant with over 25 years of experience in biopharmaceutical manufacturing, specializing in sterile injectables. He is a member of the Regulatory Governance Team at BioPhorum and part of the PDA’s Paradigm Change in Manufacturing Operations team, focusing on quality risk management and post-approval change strategies. Janmeet has held leadership roles in the Bioprocess Systems Alliance and ASME-BPE, and supports CMC submissions for mAbs, viral vectors, and ADCs in the CDMO regulatory team. He holds a Ph.D. in Pharmacology and certifications in project management and regulatory affairs.

Andrew Koch is a customer applications specialist at MilliporeSigma, supporting bioprocessing customers in sterile filtration with a focus on single-use redundant filtration and pre-use post-sterilization integrity testing. He has presented at several conferences and workshops on single-use final filtration assembly design. Andrew has a B.S. in medical biology from the University of New England and an MBA from Southern New Hampshire University.