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Novartis turns cell therapy skill into contract manufacturing deal

In an unusual arrangement, the Swiss pharma will make Carisma Therapeutics' experimental cell therapy at its Morris Plains factory, part of its plans to build up a CMO business.

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Novartis will manufacture an experimental cancer cell therapy for the small Philadelphia-based Carisma Therapeutics in a deal that marks another early step in the Swiss pharmaceutical company's efforts to build a contract manufacturing business around biotech drugs.

  • Novartis, maker of the CAR-T cell treatment Kymriah, has spent years expanding its production capacity for the complex medicines, which involve genetic engineering of immune cells to attack cancers. With the Carisma agreement, Novartis is turning that expertise outwards, agreeing to produce the biotech's experimental drug at its cell therapy site in Morris Plains, New Jersey.

  • Last year, Novartis set up a contract manufacturing organization, dubbed "Global Biotech Cooperations," and agreed to help BioNTech and CureVac make their coronavirus vaccines and Roche produce its arthritis drug Actemra, which was in testing as a COVID-19 treatment. Making cell therapies is no easy task. Unlike small molecule pills, or even protein-based drugs, cell therapies consist of whole living cells, which are carefully modified to express specific target-seeking receptors and then multiplied many times over.

Even Novartis, which with Kymriah won the first U.S. approval of a CAR-T therapy, has repeatedly run into challenges making the treatment to its approved specifications.

For smaller biotechs, the challenge is great enough that many turn to contract manufacturers like Catalent and Lonza for help. Novartis, as the deal with Carisma suggests, seems to see an opportunity to offer similar services with the production capacity it's built in Morris Plains and elsewhere.

For now, Novartis has kept a relatively low profile for its contract manufacturing ambitions, alluding to them only in announcements of previous deals with BioNTech, CureVac and Roche.

"As one of the world's largest producers of medicines, Novartis can mobilize its manufacturing capacity in an efficient way on multiple fronts," said Anton Gerdenitsch, head of contract manufacturing at Novartis Technical Operations, in a statement on the Carisma deal. The drugmaker next year will begin making Carisma's experimental treatment, which is in early testing for solid tumors.

A website for Global Biotech Cooperations gives some sense of the services Novartis will offer, noting capabilities in microbial manufacturing, plasmid DNA and RNA, viral vectors and cell bank production. The business is already making money for Novartis, which recorded $108 million in contract manufacturing sales for 2021 after reclassifying from "other revenue."

Novartis lists sites in the U.S., Austria, Belgium, Switzerland, France, Slovenia and Singapore as part of its contract manufacturing network. While the company is expanding contract manufacturing around biotech, cell therapies and genetic medicines, it's also considering selling or splitting off its generic drug business Sandoz, which has struggled in recent years selling copycat pills.

By Ned Pagliarulo, Lead Editor

BioPharma Dive March 10, 2022

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