Novartis-MIT Partnership Will Study Continuous Manufacturing
Looking to transform how pharmaceuticals are made, Novartis and the Massachusetts Institute of Technology have launched a long-term research collaboration.
Novartis will invest $65M over the next 10 years for research activities at MIT (Cambridge, Mass.), establishing the Novartis-MIT Center for Continuous Manufacturing. The goal is to develop new technologies that can replace conventional batch-based systems for manufacturing pharmaceuticals.
“Pharmaceuticals is the last of the chemical processing industries to come around to continuous manufacturing,” says Bernhardt Trout, an MIT associate professor of chemical engineering who is running the new Center. “It won’t be easy.”
According to Trout, other industries such as petroleum and especially food have been embracing continuous manufacturing, but it took them a long time to develop the processes. “There have been grumblings (about going to continuous processing) in the pharmaceutical industry for some time, but a new set of technologies need to be developed in order for it to happen. This requires a transformation.”
One potential hurdle in the process is the FDA. Trout has already had discussions with the agency. “There is a general conservativeness in the industry. This will demand effort and vision from all parties.”
The FDA may be open to this vision. According to the FDA report “Critical Path Opportunities Initiated During 2006”, FDA is working with Novartis to develop a case study of a quality-by-design approach to manufacturing drug substance and drug product. This approach identifies critical processing variables (environmental and process factors, raw materials attributes) and systematically determines their effect on performance and quality. The goal is the development of new manufacturing approaches that improve sponsors' ability to assess and improve product quality. PAT tools (e.g., near-infrared and Raman spectroscopy and chemical imaging) are being developed to monitor critical manufacturing steps to provide quality assurance and to interface with process control.
In addition, it appears that regulatory definitions are already in place to support the concept of a period of time, being a “batch”. At ISPE’s national meeting last year, FDA’s Joe Famulare, gave a presentation where he defined a “batch” using a time-based paradigm. FDA is putting together a draft guidance to provide more details.
The expected benefits of continuous manufacturing include: accelerating the introduction of new drugs by designing processes earlier; using smaller production facilities with lower building and capital costs; minimizing waste, energy consumption and raw material use; monitoring quality assurance on a continuous basis; and enhancing process reliability and flexibility to respond to market needs.
The funding will supply equipment and help support the research efforts for 7-10 faculty members, as well as dozens of graduate students, post-doctoral fellows and staff scientists. Walter Bisson will be the program manager on the Novartis side. “This is a great educational opportunity at MIT for students and post-docs to work with industry on truly cutting-edge technology,” says Trout.
According to Trout, Novartis and MIT will jointly share the rights to any research they develop together. Each entity will control the rights to any technologies they develop on their own through the center.
In 2002, Novartis opened a drug discovery center on MIT commercial property in Technology Square. While the Continuous Manufacturing Center officially opened on September 28, Trout indicated that research activities started over the summer.