Novartis further invests in cell and gene therapy manufacture, after Kymriah approval

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Salvanegra)
(Image: Getty/Salvanegra)

Related tags: Novartis, CAR-T, Kymriah

Novartis plans to step up its capabilities of manufacturing cell and gene therapies with a new facility to be built in Stein, Switzerland.

The new facility will be built at a cost of CHF90m (€79m) and is expected to be completed by early 2020.

In terms of positions created, the company announced that initially 260 new jobs will be created and this could rise to 450 new positions over the next three years.

In addition to this facility, Novartis is currently expanding its cell and gene therapy manufacturing base – just last month​, Novartis announced that it had signed a manufacturing agreement with Cell for Cure to manufacture Kymriah.

The Paris-based company will adopt the same manufacturing process as Novartis employs at its US-based Morris Plain facility to create Kymriah. In the same press release, Novartis revealed that it expects Cell for Cure to begin manufacturing Kymriah for clinical trials and commercial purposes in 2019.

Alongside Cell for Cure, Novartis had already established a manufacturing site in Leipzig, Germany, which produces the same treatment for clinical trials worldwide and conducts post-approval manufacturing.

Manufacturing to meet demand

Adding the Swiss-based facility to its European manufacturing network was revealed shortly after Novartis received approval​ for its chimeric antigen receptor t-cell (CAR-T) therapy by the European Commission.

The two pieces of news are linked, with the new facility expected to play a role in manufacturing cell therapies, including Kymriah, for European patients.

The treatment was approved for use in paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma after two or more lines of systemic therapy.

This will require an established manufacturing process in Europe, though the company stated that it would begin to treat patients initially in B-cell ALL before being able to deliver to the second group of patients.

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