Abhinav Shukla | Sr. VP, Process Development and Manufacturing
KBI Biopharma | United States

Abhinav Shukla, Sr. VP, Process Development and Manufacturing, KBI Biopharma

Abhinav has over 15 years of experience in process development in biopharmaceuticals covering early development through commercial launch. He has led process development activities at both small biopharmaceutical and large pharmaceutical organizations and was most recently the Director, Manufacturing Sciences and Technology at Bristol-Myers Squibb. At BMS, Abhinav led an organization that successfully commercialized Yervoy® and Nulojix® and provided post-commercial process support for Orencia® in addition to other late-stage programs. Prior to BMS, Abhinav worked in the process development organization at Amgen Inc. where he was instrumental in establishing the organization wide platform process approach for monoclonal antibodies and Fc fusion proteins and aiding the progression of several biopharmaceuticals at various stages of development. Abhinav has a Ph.D. in Chemical and Biochemical Engineering from Rensselaer Polytechnic Institute. Abhinav has over 30 publications in the bioprocessing area and also serves on the journal editorial boards of “Bioprocess International” and “Biotechnology and Applied Biochemistry” and has presented keynote lectures at international conferences in the field of process development and manufacturing of biopharmaceuticals

Appearances:



Conference Day 1 @ 14:40

Highly accelerated platforms for mAb and next generation mAb development

  •     Key elements of a mAb platform enabling gene to GMP in 9 months
  •     High throughput process development tools for developing next generation mAbs
  •     Challenges encountered with these novel types of molecules
  •     Rapid and streamlined process characterization and validation studies to enable BLA/MAA filings for breakthrough therapies and biosimilars 

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