CBI and MIT faculty are developing continuous manufacturing approaches to meet the growing demand for viral vector gene therapies based on mechanistic modelling and novel analytical technologies.
CBI and MIT faculty are developing an easy-to-use, low-cost platform that will enable manufacturing of small quantities of AAV gene therapy drug product to accelerate the development of treatments for ultra-rare diseases.
CBI and MIT faculty are developing novel PAT for real-time assessment of protein quality and rapid methods to assess viral contamination in continuous manufacturing of monoclonal antibodies.
This project will gather information on microbiological contamination events encountered during cell therapy manufacturing from industry, academic, and governmental organizations. The goal of this international collaborative effort is to develop a resource that can be used by practitioners to inform adventitious agent risk mitigation strategies and facilitate the development of rapid adventitious agent detection platforms that will enable the timely delivery of safe cell therapy product to patients.
CBI is developing a mechanistic understanding of viral vector production and purification to enable the development of novel manufacturing control strategies and purification approaches.
CBI is a part of SMART CAMP, an international research effort focused on developing the analytical tools and biological understanding of cell therapy critical quality attributes that will enable the manufacture and delivery of improved cell therapies to patients.
CBI and MIT faculty are developing new approaches for using data sources and data analytics in biomanufacturing to better inform operational models and regulatory decision-making.