Demonstration of Low-Cost Monoclonal Antibody Manufacturing

Anurag Rathore of the Indian Institute of Technology (IIT) Delhi with Abhishek Mathur of Enzene Biosciences Limited, both in India, will pilot test a continuous processing platform for monoclonal antibody biomanufacturing for its advantages compared to batch processing. The pilot will build on lessons from the platform operating at the Center of Excellence for Biopharmaceutical Technology at IIT, Delhi. It will demonstrate that the existing biomanufacturing platform in an academic setting can be scaled up in a commercial setting. It will validate the decreased cost of goods and increased production relative to batch manufacturing, and it will provide technical and economic data, with details on integrating operations from cell culture through final formulation into a seamless, automated process. This data will guide efforts to increase access and affordability of monoclonal antibody products by manufacturing them in low- and middle-income settings.