Top tips to optimize downstream processes
From resins to buffers to single-use technologies – there are many opportunities to improve downstream processes
Emerging treatments, including cell and gene therapies, are exciting and are certainly starting to expand pipelines. However, traditional biologics (monoclonal antibodies) still dominate the world of biopharma. Research has shown that the clinical pipeline of antibody therapeutics grew by 30 percent over the past year (1) – excluding COVID-19 antibody therapies – highlighting the importance of these treatments and the need for their efficient production. Given that 60–80 percent of mAb production costs can be attributed to downstream processing (2), removing downstream bottlenecks and improving yields will continue to be an important priority for mAbs manufacturers – especially amidst rising demand.
The following article, published in The Medicine Maker is offering a few suggestions.
Authors
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.
Dr. Jungmin Oh
Manager, New Product Development
In her current role, Jungmin leads product and process development projects with multiple biopharmaceutical industry partners, including customized product development for cell and gene therapy customers. She holds a MS and Ph.D. in chemical engineering, specializing in the optimization of a continuous chromatography system.
Dr. Jonathan Fura
Previously held: Manager, Research & Development
Jonathan focused on developing technologies that are utilized to advance the development and manufacturing of antibody-based biopharmaceuticals and diagnostics. Jonathan holds a Ph.D. in chemistry with a focus on developing immunomodulation therapeutic strategies.
Dr. Pranav Vengsarkar
Manager, Research & Development – Biopharma Production
Pranav Vengsarkar, Ph.D., is Manager, Process Development at Avantor, focused on product and process development for new cGMP products and excipients, and development and design of single-use raw material delivery systems. Pranav holds a Bachelor of Chemical Engineering degree from ICT, Mumbai and a Ph.D. in Chemical Engineering from Auburn University.