In Biopharmaceutical Manufacturing, the process is the product, and improving upstream processes alone is not enough, downstream damage control is crucial too.
In this talk, Dr.
Tiwari talks about the challenges in Bioprocess Manufacturing, which occur due to variabilities in the process.
Variabilities can arise in the cell culture process as well as the purification process, and need to be monitored, assessed and controlled.
Dr. Tiwari highlights the need and importance of in-process analysis of cell culture spent media by LC-MS/MS, with a case study on Cell Culture Profiling using Shimadzu LCMS-8060, which enables simultaneous monitoring of culture medium components. Based on the study on Cell Culture profiling, the media feed was optimized and a robust process control was established. This talk also covers the strategies which can be employed for robust manufacturing of a biosimilar, including process design for control of variability and the use of predictive modelling.
In Collaboration with:
Sanjay Tiwari (Ph.D.)
Director for Biotech Research
Lupin Limited, Pune
Dr. Tiwari is currently working as the Director for Biotech Research at Lupin Limited, Pune. Upon the completion of his PhD in Biochemical Engineering and Biotechnology at IIT Madras, Dr. Tiwari has worked for the major Biopharma companies like Biocon, Cadila Pharma, Anthem Biosciences, Lupin Limited. He has an extensive experience of 24 years in development and manufacturing of biosimilars, novel biologics and fermentation based small molecules. He has a deep expertise and knowledge in research, process development and analytics, scale-up and manufacturing support, CMC and project leadership, process design and operational excellence.