Increased Viral Clearance in Downstream Process Manufacturing Through Use of Novel Purification Resins and Additives
Downstream processing of monoclonal antibodies, which involves multiple chromatographic purification, buffer exchange, and viral inactivation steps, remains the major bottleneck in the manufacturing of these biologic molecules. The evaluation and selection of proper materials and reagents during process development is crucial in developing and optimizing a robust purification process that ensures that in-process impurities from upstream production are removed.
In this presentation, we will discuss the development of a novel affinity chromatography resin, PROchievATM. We will show that PROchievATM provides enhanced purification of monoclonal antibodies and when used in combination with select additives, enhances the removal of impurities such as host cell protein, DNA, and viruses. Furthermore, we will show how PROchievATM provides increased purification of Fc-fusion proteins, and when properly utilized in conjunction with subsequent downstream purification steps, can lead to improvement in overall manufacturing process efficiency of mAbs.
This presentation was given during BPI Europe, Vienna, May 17-19, 2022.
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.