The rewards of planning ahead: designing for full cGMP production at pilot scale
It is essential that the raw materials used to manufacture gene therapies meet current good manufacturing practice (cGMP) quality standards and specifications to ensure productivity and patient safety. This includes quality control testing of incoming raw materials, increased documentation to show manufacturing control and robust process validation.
This article reviews critical areas where early use of cGMP raw materials may help to avoid additional costs, potential process re-development and lost production time. Choosing a partner with extensive experience in manufacturing biological products and access to a broad portfolio of quality products, from multiple qualified sources, provides greater supply assurance and transparency.
ABOUT THE 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.