Sunday, May 31, 2009

Collaboration Could Provide Makeover for Drug Manufacturing

Novartis and MIT team to develop new continuous manufacturing processes

NOVARTIS (BASEL, SWITZERLAND) and the Massachusetts Institute of Technology (MIT, Cambridge, Mass.) have launched a long-term research collaboration aimed at transforming drug manufacturing.

The planned 10-year, $65 million partnership, known as the Novartis-MIT Center for Continuous Manufacturing, seeks to develop technologies that could replace the long-standing batch-based method used to produce traditional pharmaceuticals with more up-to-date continuous manufacturing processes.

Novartis believes drug manufacturing technology has been neglected. "Our collaboration with MIT holds the promise to achieve a quantum leap in the production of pharmaceuticals, a field which has received rather little attention in the past," says Daniel Vasella, MD, chairman and chief executive at Novartis.

Current batch-based techniques dominate small-molecule drug manufacturing-though certainly not the making of more complex biotech drugs-even though other industries have shed such process-intensive methods for more streamlined continuous manufacturing techniques.

In batch processing, active ingredients are synthesized in a chemical manufacturing plant and shipped to a manufacturing facility, where drug makers may mix and store compounds until needed. Further processing involves chemical reactions that must be tightly controlled. The drug-making process can take weeks.

Drug companies have relied on batch manufacturing for years, and batch processes are now intertwined with the market approvals granted by regulators for certain products at particular manufacturing facilities. Such approvals can motivate companies to maintain the process status quo, given the costs, time, and risk involved in getting new processes approved.

Expected benefits of continuous manufacturing include accelerating the introduction of new drugs by designing production 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 instead of using post-production batch-based testing; and enhancing process reliability and flexibility to respond to market needs.

Our collaboration with MIT holds the promise to achieve a quantum leap in the production of pharmaceuticals, a field which has received rather little attention in the past.

-DANIEL VASELLA, MD, chairman and CEO, Novartis

MIT associate professor of chemical engineering Bernhardt Trout, PhD, has been named to run the program. Initial research work will be conducted primarily through PhD programs at MIT laboratories and then transferred to Novartis for further development.

The partners expect the work to involve seven to 10 MIT faculty members, as well as students, postdoctoral fellows, and staff scientists. Novartis reports it will commit its manufacturing and research and development resources and will pilot new manufacturing processes with one of its pharmaceutical products.

Novartis and MIT expect the technologies created in this collaboration to benefit patients and healthcare providers with improved supply and quality of medicines. Their research will also investigate ways to reduce the environmental impact of manufacturing activities.

The collaborators will share the rights to any research they develop together, with each company controlling the rights to technologies it develops alone through the center. They could also generate revenue by licensing technologies to other companies. �

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