Efficient raw material management for improving bioprocess throughput and flexibility

There has been significant change across the biomanufacturing industry over the last couple of decades, as increased complexity of biologics and a growing focus on smaller patient populations have led to a greater need for process flexibility and efficiency as well as cost control. As productivity has improved as a result, so too have titers and other areas of process development. Typical biologic manufacturing consumes hundreds of raw materials including media, supplements, single-use systems, process chemicals, filters, resins, and excipients. Buffers are one of the largest constituents by volume used in the production of most modern biopharmaceutical products. The various compositions of buffers used across a biopharma manufacturing facility requires inflexible & cost-inefficient infrastructure for support and has several contamination risks. Any deviation from the standard in these raw materials typically requires significant micro-management to resolve, resulting into prosecution delays and losses.

While buffer in-house manufacturing is an established method specifically for larger volumes, the adoption of hydrated, pre-made liquid buffers and buffer concentrates is a cost-, time- and resource-saving as well as risk mitigating alternative for multi-batch facilities or small-scale manufacturing of mAbs and novel therapeutics.

These single-use liquid formulations when combined with innovative new technologies like in-line dilution can help reduce facility footprint, labor hours and overall cost-of-goods. This presentation will give an overview of the challenges in raw material management with a risk/benefit analysis of liquid handling options to overcome some of these issues.

This presentation was given during BPI Europe, Vienna, May 17-19, 2022.

Presented by:

		Ph.D., MBA, 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.