Resources, redundancy & resilience: overcoming risk in C & GT production
Clinical development of viral vector gene therapies has outpaced CMC, manufacturing, and formulation development, creating process challenges that impact quality and shelf-life; most notably a lack of standardized methods and product usage, raw materials that are not cGMP grade and material supply insecurity.
This state of flux presents unique opportunities to de-risk the cell and gene manufacturing processes, and there are a multitude of approaches to improve manufacturing efficiency.
Author
Dr. Nandu Deorkar
Senior Vice President, Research & Development – Biopharma Production, Avantor
Nandu Deorkar is Senior Vice President, Biopharma Production Research & Development for Avantor. He is responsible for innovation strategy and planning, and execution of new products and technology development. During his more than 25-year career in research & development, Dr. Deorkar has been leading teams working on various aspects of upstream and downstream bioprocessing, single use systems, chemical/polymer R&D, drug development, formulation, drug delivery technologies, process development, and technology transfer. He has published more than 30 articles and holds more than 20 patents. Dr. Deorkar received Ph.D. from Indian Institute of Technology, Mumbai, India and MBA in Marketing from Fairleigh Dickinson University, Madison, NJ, USA.