Implementing and Managing Pre-use Post-sterilization integrity testing (PUPSIT)

Partha Banerjee is a Technical Application Expert at Merck with over 17 years of experience in downstream bioprocessing and biopharmaceutical process development. He specializes in sterile filtration, filter optimization, troubleshooting, and regulatory-aligned validation strategies. Known for translating scientific concepts into practical solutions, he supports biopharma manufacturers in achieving robust and compliant processes. Partha holds a Master’s degree in Pharmaceutical Chemistry and has expertise in IPR and patent management.

Nitish Kumar is the Head of Customer Applications, Downstream Processing (South Asia) for Merck, in Bangalore. He provides technical consultation and customer-centric solutions for downstream processing in South Asia. Previously, he served as Technology Manager, offering consultative expertise in process development and scale-up of biopharmaceutical applications for biological manufacturers. He holds a postgraduate degree in Biotechnology from S.P University and has over 17 years in the biopharmaceutical industry, managing bioprocesses for early and late-phase clinical material.