Recent research from the Bill & Melinda Gates Medical Research Institute emphasizes the need for innovative bioprocessing technologies to lower the costs of monoclonal antibody (mAb) production. This reduction in production costs could enhance patient access to mAb therapies.
Lead author Chun Chen, PhD, highlights that while manufacturing costs alone do not dictate market prices, they establish a critical baseline for affordability. He points out that as other cost factors are optimized, the significance of manufacturing costs will inevitably increase, particularly for biosimilars which are vital for treating chronic and infectious diseases in lower-income regions.
Chen notes that the production costs for mAbs have significantly decreased in recent decades thanks to advancements like improved Chinese hamster ovary (CHO) cell lines, optimized culture media, and enhanced processes. Collectively, these innovations have led to greater productivity and facility efficiency.
However, Chen warns that without major technological breakthroughs, further cost reductions will be difficult to achieve. He identifies potential limits in current production capabilities, such as the constraints on CHO cell productivity and bioreactor volume.
Automation has already played a significant role in decreasing mAb production costs. Chen believes that further investments in automation can yield additional savings by minimizing labor costs, reducing errors associated with human operators, and enhancing product quality.
Moreover, he asserts that artificial intelligence (AI) can greatly influence the mAb development and manufacturing process. By integrating rich domain knowledge and data with AI tools, or utilizing traditional modeling and optimization methods, the production process can be improved. Chen acknowledges that while initial investments in AI may not yield immediate benefits, the long-term impact on cost savings will be substantial.