Novartis Gives $65M To MIT To Develop New Ways To Make Drugs And ‘Transform Industry’

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cauldron.jpgThe idea is to create a research program aimed at revolutionizing the way drugs are made. And so 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, The Boston Globe writes.

The funds, which will be provided over 10 years, 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,” says Bernhardt Trout, an MIT associate professor of chemical engineering who is running the new Novartis-MIT Center for Continuous Manufacturing. “This is going to be an industry transforming project.”

He says drugmakers currently rely on batch manufacturing simply because they’ve always done so and don’t have the knowledge to make a switch. “We need to develop a whole of new set of technologies that don’t exist,” he says. “We’re the first ones to try to put together all the resources to make it happen.”

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.

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 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 execs say they are a long way from converting to a fully continuous model. “It would be quite a challenge,” says Steve Kennedy, a Genzyme senior vp.

For that reason, MIT’s Trout said, the research center plans to focus first on manufacturing drugs made from chemicals. In addition, the FDA 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 vp at PhRMA. But Loew credits the FDA with being more flexible recently to help drugmakers improve their manufacturing processes.

FDA spokesman Christopher Kelly said the agency supports the move to continuous manufacturing. “We recognize there have been hurdles,” he says. “We have and are continuing to work to overcome them.”

MIT officials said the program has been quietly gearing up since June. Novartis ceo Dan Vasella and MIT president Sue Hockfield plan to formally launch the program in a ceremony this afternoon at MIT. 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.

Here’s the Novartis statement.

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  1. While it is more than comendable to put significant resources behind manufacturing research and engineering, an area that has been surely forgotten in engineering departments across the country during the genome craze, continous processes have already been investigated and found to run into fundamental regulatory issues.

    For starters, the entire FDA and QA/QC philosphy hinges on “the batch”. What is a “batch” in continous times ? Where does it start and where does it end ? How do we get the FDA (and EMEA) to depart from the search for batches ? And if things go wrong which “batch” do you want to recall ?

    Serono, Bayer and Baxter had their brush with continous production of biologics in the mid-90s and most abandoned it, because of fundamental regulatory issues in addition to the technical challenges. And there are a number of advantages in batch operations not to be forgotten.

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