The Belgian site will be created through the joint investment of Legend Biotech and Janssen, providing the partners additional capacity as they prepare for commercial roll-out of cilta-cel (ciltacabtagene autoleucel).
February this year saw the European Medicines Agency (EMA) provide their investigational CAR-T therapy with an accelerated assessment of its Marketing Authorization Application (MAA). The US Food and Drug Administration (FDA) also provided Priority Review for the potential treatment of relapsed/refractory multiple myeloma.
For Legend Biotech, the investment represents an expansion of its manufacturing footprint into Europe, where it will “leverage the strong Belgian life sciences ecosystem,” said Liz Gosen, the company’s SVP of global technical operations.
The companies did not provide further detail on exactly how much capital the partners would be investing in their newest facility.
Legend Biotech was created last year, after a spinoff from GenScript Biotech Corporation. The biotech raised $428.8m (€359.2m) as part of its IPO, with it confirming at the time that approximately $60m to $75m would be set aside for the construction of manufacturing facilities.
Building out global manufacturing network
For a biotech without an approved product, Legend Biotech already has a substantial manufacturing network, with two manufacturing locations in the US, based in Raritan and Somerset, New Jersey, and an additional location in Nanjing, China.
When asked about the size of Legend Biotech’s manufacturing network, a spokesperson answered the company is “working to establish a global manufacturing network for robust and cost-effective cell therapy supplies.”
Due to the nature of the production of CAR-T products, proximity to patients is crucial making the Belgium location suitable for potential delivery to patients in Europe. Though on this point, the spokesperson confirmed that its manufacturing facility in Raritan is equipped for commercial supply for the US, European and Japanese markets, and is currently operational.
The biotech has reserved sufficient capacity to meet anticipated peak US demand in this particular facility, the spokesperson confirmed. While its Chinese facility is also operational and expected to meet demand in the same country.
The spokesperson confirmed that these two facilities were built in conjunction with Janssen, as well as the announced facility.
Legend Biotech’s additional US location, in Somerset, will be utilized for the company’s own pipeline of products, and is expected to provide clinical supply once operational.