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Innovation in Manufacturing Biomedicines: From New Modalities to Scalable, Accessible Therapeutics
Stacy Springs
Executive Director, MIT Center for Biomedical Innovation (CBI)

Biologic medicines (e.g., monoclonal antibodies, gene and cell therapies, vaccines) are critical to treating and preventing disease. Recent regulatory approvals of exciting new biomedicines such as cell and gene therapies provide new hope to patients who have exhausted alternative therapies or suffer from a rare disease with no other treatment. To help patients access these medicines, biopharmaceutical companies must be able to manufacture very complex molecules safely, reliably, and in the quantities needed, which can range from the very large (industrialized) scale to the very small (personalized) scale. This presentation will review the challenges in manufacturing these complex biologic medicines as well as approaches to modernization of biomanufacturing with the goal of providing broadened access to biologic medicines. Dr. Springs will describe multiple approaches that MIT’s  Center for Biomedical Innovation and collaborators are taking to achieve this goal, including continuous manufacturing, novel purification strategies, novel analytical technologies for assessing novel product quality attributes, and rapid methods for sterility and viral safety assessment.