Rahul Fadnis | Head, Viral Testing Facility
Syngene International Limited | India

Rahul Fadnis, Head, Viral Testing Facility, Syngene International Limited

Dr. Rahul S. Fadnis, PhD, is a biotech professional with over 13 years of industry experience in the areas of Viral Safety, Clearance and Vaccine Development. He heads the Viral Testing Facility at Syngene International Limited that offers the Viral Clearance and Safety studies to Indian and Global Biopharma Industry. In his previous role, he worked for Biocon Limited for over 7 years and was leading the Biosafety group at R&D centre. His work focussed on conducting the cell bank characterization studies on the mammalian cell banks expressing therapeutic recombinant proteins. Being virologist by profession Rahul was actively involved in viral assays development both in-vitro and molecular based platforms for detection of retro and adventitious viruses from recombinant protein products expressed in mammalian systems. He has been instrumental in development of sensitive assays for detection of residual DNA from protein product intermediates of a manufacturing process. Rahul also holds experience of conducting viral clearance studies on the downstream manufacturing process for recombinant proteins, novel as well as biosimilars. He has also worked with Ranbaxy and Serum Institute of India, Pune, India to work on bacterial vaccine manufacturing. He has completed his PhD from National Institute of Virology, Pune, India. Rahul has several publications in peer reviewed journals and patent to his name. He is an active participant in Viral safety forums held globally.

Appearances:



Conference Day 2 @ 11:45

Viral safety testing and clearance in biopharma industry

  •     Overview of viral contamination events in the Biologics Industry
  •     Consequences of the viral contamination in Biologics drugs
  •     Importance of viral risk mitigations in ensuring safety of drugs
  •     Regulatory expectations for viral safety in Biologics
  •     Syngene’s  support towards meeting viral safety requirements of the Biologics manufacturers

Conference Day 2 @ 12:10

Combined Q&A

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