Quality by design aproaches to clarification in monoclonal antibody processing

Subhasis Banerjee is the Principal Process Consultant in the Technical & Scientific Solutions group of Process Solutions at our company based out of Bangalore, India. Subhasis supports technical consultation on Process Development , Scaleup and troubleshooting for downstream processing for the APAC region, working for the last 18 years in our company. He is a Ph.D. in Biochemistry with a post-doctoral experience from The Ohio State University, Columbus, Ohio, USA. Dr. Banerjee has several publications in international peer reviewed journals and presentations in several national and International Conferences.

Kevin Yeop holds a Master’s degree in Chemistry and Biotechnology from Ajou University. At our company, he is responsible for downstream process development, specializing in TFF and Vaccine and Viral Gene Therapy (VVT) as a global focal point and Korea representative in DSP MSAT. He supports technical partnerships across drug development phases. Previously, he has spent over 12 years at our company, SK Bioscience, Osstem Implant BPD, and CJ Bio Institute, focusing on process development. His expertise spans purification, analytical method development, and cell culture optimization, including scale-up. He notably managed CDMO projects for COVID-19 vaccines and led process development for recombinant proteins, covering DS, DP, and analytical method establishment for novel biologics.