A collaborative ecosystem: Accelerating the commercial manufacturing of novel vaccines and other therapeutics
Over the last 35 years, the biopharmaceutical industry has made significant contributions to improving human health outcomes by developing and commercializing recombinant protein and monoclonal antibody (mAbs) therapies. 2021 marked the FDA’s approval of its 100th mAb therapy while simultaneously, groundbreaking research has resulted in safe and effective nucleic acid and gene therapy platforms.
Innovation in these areas enabled the rapid commercialization of vaccines for COVID-19 and will continue to drive the future of medicine; however, the industry will need to achieve greater efficiencies and scale for its manufacturing and supply chain processes for innovation to continue to translate to successful, sustainable commercialization.
This presentation discussed how suppliers and manufacturers can partner to overcome the challenges of drug development related to the scale-up, technology transfer, regulatory considerations, and commercialization timelines of bringing new therapies to market.
This keynote presentation was given during BPI Cell&Gene Therapy Manufacturing & Commercialization, September 28, 2021
Dr. Nandu Deorkar Vice President, Research & Development – Biopharma Production
During his more than 25-year career in materials technology research & development, Dr Deorkar has worked on various aspects of chemical/polymer R&D, drug development, formulation, drug delivery technologies, process development, and technology transfer. Dr Deorkar earned his PhD in chemistry from the Indian Institute of Technology, Bombay, and his MBA from Fairleigh Dickinson University, New Jersey (USA).