Advancing next gen biologic manufacturing by implementing continuous downstream processing platform

An integrated downstream process is needed to efficiently support ever increasing pipeline and demand of mAbs in clinical development. In spite of several technological advancements, downstream is still a major bottleneck.

An average biologic manufacturing process consumes hundreds of raw materials/consumables. Herein, we will present an integrated continuous downstream purification process that utilizes a novel approach to connect several chromatography steps along with use of single-use powder dispensing and hydrated buffers to improve flexibility, throughout and cost of goods. Additionally, we demonstrated the use of novel additives and resins to increase impurity clearance to meet quality while reducing process time.

his presentation was given during BPI Europe, May 10, 2023.

Presented by:

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.