Umesh Kapse

Biography

Assistant Manager Company Name Serum Institute of India Limited Dates Employed Mar 2016 – Present Employment Duration 1 yr 7 mos Location Pune Area, India Work Experience: Monoclonal Antibodies Purification • Process development/Characterization/Optimization and process scale up upto 1000 L for purification of Monoclonal Antibodies • Data interpretation (Process and Analytical) • Lab Setup for R&D Scale and Facility set up for 1000L scale. • Equipment qualification- chromatography systems, Chromaflow columns, Column packing station, peristaltic pump, weighing balance, Process Vessels, pH and conductivity meter etc. • Preparation of equipment SOPs and process related SOPs for purification of MAb. • Preparation of MFR, BMR for 1000L scale MAb purification process. • Cleaning validation and process validation. • Planning and execution of commercial batches of monoclonal antibodies at 1000L scale as per GMP compliance. • Change control and deviation management.

Research Interest

Pharmaceutical company