Drug giant Novartis AG says it will give its Cambridge neighbor, MIT, $65 million over 10 years to create a research program, likely to be the biggest in the world aimed at revolutionizing the way drugs are made.
The goal is to help companies move from making drugs in batches to using a continuous high-tech process that will save time and money.
"It would be a sea change," said Tom Van Laar, global head of technical operations for the Swiss company, which over the past five years has established two major drug divisions in Cambridge - including its global headquarters for drug research - that employ about 1,500 scientists and other workers. The partnership with the Massachusetts Institute of Technology, set to be formally unveiled today, underscores the symbiotic relationship between the region's booming life sciences sector and its academic research institutions. It also bolsters Massachusetts' efforts to become a center for drug manu facturing. The Boston area is already one the nation's biggest biotech research hubs.
Increasingly, the state is becoming a place where biotech companies make drugs as well as create them. Bristol-Myers Squibb, one of the world's largest drug companies, is building a $750 million biotech manufacturing facility on the site of the former Fort Devens US Army Base. Earlier this month, Cambridge biotech Genzyme Corp. broke ground on a $150 million expansion of its manufacturing plant in Allston. Wyeth, another global drug company, already operates a major biotech manufacturing center in Andover. Novartis bases its US drug manufacturing in New York and California.
MIT said the $65 million agreement with Novartis - one of the school's largest industrial research collaborations ever - should be enough to support research efforts for seven to 10 faculty members, and dozens of graduate students, postdoctoral fellows, and staff scientists. MIT officials believe it will be the largest academic research effort in the world focused on modernizing drug manufacturing.
"There is nothing of this magnitude and this focused," said Bernhardt Trout, an MIT associate professor of chemical engineering who is running the program, called the Novartis-MIT Center for Continuous Manufacturing. The bulk of the funding, $40 million, is expected to come in the first five years of the agreement, Trout said.
But making the leap to continuous manufacturing won't be simple. Unlike the assembly line process used to make cars, drug manufacturing typically involves a series of carefully controlled chemical reactions, which could be spoiled by contamination, a minor fluctuation in temperature, or other factors.
Traditionally, the process is broken into dozens of individual steps - each one involving interruptions. For instance, drug makers might mix several chemical compounds together in a vat, test and purify the batch, and store it until it is ready for the next step. For a move to continuous manufacturing, raw materials would have to be constantly pushed through an automated system. .
Trout said companies currently rely on batch manufacturing simply because they have always done so and don't have the knowledge required to make the switch.
"We need to develop a whole of new set of technologies that don't exist," he said. "We're the first ones to try to put together all the resources to make it happen."
A continuous-production model could be even more difficult when it comes to biologic drugs - those made from living organisms - that are key to the state's life sciences industry. For instance, Genzyme makes the biotech drug Myozyme at its Allston plant in a series of complex steps that include growing specially engineered Chinese hamster ovary cells to manufacture proteins. Genzyme has already made some incremental changes at the plant, but company executives say they are a long way from converting to a fully continuous model.
"It would be quite a challenge," said Stephen Kennedy, a Genzyme senior vice president.
For that reason, MIT's Trout said, the research center plans to focus first on manufacturing drugs made from chemicals.
In addition, the Food and Drug Administration usually must approve any change in a drug maker's manufacturing process, which could discourage some companies from adopting new techniques.
"The ability for a company to employ a new approach is significantly hampered by the way companies are regulated," said Caroline Loew, a senior vice president for the Pharmaceutical Research and Manufacturers of America, an industry trade group. But Loew credits the FDA with being more flexible recently to help pharmaceutical companies improve their manufacturing processes.
FDA spokesman Christopher Kelly said the agency supports the move to continuous manufacturing.
"We recognize there have been hurdles," Kelly said. "We have and are continuing to work to overcome them."
MIT officials said the program has been quietly gearing up since June. Novartis chief executive Daniel Vasella and MIT president Susan Hockfield plan to formally launch the program in a ceremony this afternoon at MIT.
MIT and Novartis will jointly share the rights to any research they develop together, and each will control the rights to any technologies they develop alone through the center. They could also generate revenue by licensing technology to other companies.
In addition to the $65 million, Novartis also pledged to pool its manufacturing and research resources with MIT and use the company's drugs to test new manufacturing techniques. But despite Novartis' involvement, MIT's Trout believes the program's work will quickly be adopted by other drug companies.
"This is going to be an industry transforming project," he said.
Todd Wallack can be reached at firstname.lastname@example.org.