🧪💡 MIT and Federal Government Collaborate on $82M Project to Revolutionize mRNA Manufacturing
The Massachusetts Institute of Technology (MIT), in partnership with the federal government, embarks on an ambitious endeavor to design and implement an innovative continuous mRNA manufacturing platform. With $82 million in funding from the FDA’s Center for Biologics Evaluation and Research (CBER) over three years, this groundbreaking project aims to advance mRNA therapeutics and foster collaboration within the biopharma industry.
By providing a template for continuous manufacturing, MIT’s initiative will enable other companies to streamline their production processes while enhancing agility and adaptability to address emerging health threats globally. Peter Marks, Director of CBER, emphasizes the public health significance of this venture, recognizing the potential of a continuous mRNA manufacturing platform to tackle health challenges with speed and precision.
MIT researchers, along with collaborators from Penn State University, will undertake the engineering aspects of the project. Additionally, CDMO ReciBioPharm has been subcontracted to implement the pilot manufacturing site, ensuring practical implementation of the platform.
MIT assures close collaboration with the FDA to adhere to good manufacturing practices and regulatory guidelines throughout the research. Building upon the success of the Novartis-MIT Center for Continuous Manufacturing, a previous program that developed a continuous manufacturing system, this project represents a significant leap forward in shaping the future of manufacturing practices in the pharmaceutical industry.
Continuous manufacturing, a process characterized by constant production and distribution, stands as a paradigm shift from traditional batch-based production methods. As the FDA continues to establish standards and guidelines for this innovative approach, it underscores the industry’s commitment to advancing manufacturing technologies. The FDA’s adoption of guidelines for continuous manufacturing in March 2023 further underscores its dedication to shaping the future of pharmaceutical production. 🌐🧬💉
MIT and Federal Government Collaborate
