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September 28, 2007
By: Tim Wright
Editor-in-Chief, Contract Pharma
Novartis and the Massachusetts Institute of Technology (MIT) have entered a 10-year research collaboration with the goal of transforming the pharmaceutical production process. The partnership, known as the Novartis-MIT Center for Continuous Manufacturing, will work to develop new technologies to replace the conventional batch-based system, which often includes many interruptions and work at separate sites, with continuous manufacturing processes from start to finish. The partnership combines Novartis’ industrial expertise with MIT’s scientific and technological expertise. Novartis will invest $65 million in research activities at MIT during the next 10 years. “This partnership demonstrates our commitment to lead not only in discovering innovative treatments for patients but also in improving manufacturing processes, which are critical to ensuring a high-quality, efficient and reliable supply of medicines to patients. Our collaboration with MIT, a worldwide leader in developing cutting edge technologies, holds the promise to achieve a quantum leap in the production of pharmaceuticals, a field which has received rather little attention in the past,” said Dr. Daniel Vasella, chairman and chief executive officer of Novartis. “The Novartis-MIT Center for Continuous Manufacturing has the potential to revolutionize drug development and production,” said Susan Hockfield, MIT president. “We are delighted to collaborate with Novartis to help improve the way that drugs are manufactured so that patients have quicker and more reliable access to the medications they need. The new educational opportunities that this program will provide for our students make this partnership even more exciting.” Batch-based manufacturing involves the following process: pharmaceutical active ingredients are synthesized in a chemical manufacturing plant and these ingredients are then shipped to a manufacturing facility where they are converted through defined processes into large batches of pills, liquid or cream. This process involves multiple interruptions, including transport to separate locations, and each batch may take weeks to produce. Also, manufacturing design and scale-up for a new drug are expensive and time-consuming. The anticipated 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 post-production batch-based testing; and enhancing process reliability and flexibility to respond to market needs. The initial research of the Novartis-MIT Center for Continuous Manufacturing will be conducted primarily through Ph.D. programs at MIT labs, and then transferred to Novartis for further development to industrial-scale projects. Novartis will use its manufacturing and R&D resources and will pilot new manufacturing processes with one of its products.
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