Title: Implementing modern cell engineering and process development approaches for affordable and sustainable biosimilar manufacturing

Biography:

Sanjeev Gupta has obtained PhD in Molecular Biology/Cell Line Engineering and MSc in Applied Microbiology and Biotechnology. At present working as Sr. General Manager and Head, Advanced Biotech Lab (R&D-Biosimilar), Ipca Laboratories Ltd., Mumbai, India. He has established a new world class state of the art Biotech R&D facility for the development of mAb Biosimilars. He is also actively involved in establishing modern and lean single use Bio-manufacturing facility for Biosimilar commercial launch. He carries over 18 years of industrial experience and has been working since 2000 on the development of “Biosimilars” including monoclonal antibodies. So far, he developed and contributed for over ten recombinant molecules, of which Seven Biosimilar products has been already launched in the Indian market and the rest are in the developmental or clinical phase, and are expected to be launched in near future. He delivered talks conferences organized by IBC, Terrapin, IMAPAC, CPhI, Biopharma, Selectbio and UBM. He has also published several Research articles (10), Book chapters (05), Magazines (04) and Patent (01) in lieu of the Biosimilar development.

 

Abstract

I will give a General Overview of Biosimilars/ Biologics and opportunities for the Biopharma players followed by implementation of modern tools described below for affordable biosimilar and Biologisc development:

1.      Implementation of Gene editing tools CRISPR and TALENS for cell line engineering and production improvement

2.      Modern approaches for high producer cell line and robust upstream process development

3.      Use of cutting edge technologies to improve biosimilar development and manufacturing

4.      Factors influences protein expression and critical quality attributes including glycosylation of monoclonal antibodies

5.      mAb glycosylation and its overall Impact on biosimilarity and product performance

6.   Case studies on titer and quality improvement at clone and process level for affordable biosimilar development