Catalent has entered a strategic partnership with Galapagos to facilitate decentralised manufacturing in the US for the trials of the latter’s CAR-T therapy, GLPG5101, aimed at treating relapsed/refractory non-Hodgkin lymphoma (NHL).
This manufacturing approach will support upcoming studies in New York, New Jersey and nearby regions leveraging Catalent’s commercial cell therapy manufacturing facility in Princeton.
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The financial terms remain undisclosed.
Catalent global cell therapy and plasmid DNA vice-president Delara Motlagh said: “Catalent is passionate about increasing patient access to life-changing cell therapies like those being developed by Galapagos.
“We are delighted by this collaboration to support Galapagos’ decentralised cell therapy approach to bring these pioneering treatments to more patients with certain aggressive forms of NHL in a median vein-to-vein time of seven days.”
Galapagos’ decentralised manufacturing platform is tailored to be established close to centres that provide cancer treatment, potentially benefiting NHL patients.
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By GlobalDataIt claims to offer a “fresh” and “stem-like” early memory cell therapy. This approach could eliminate the need for cryopreservation and bridging therapy.
The platform features an end-to-end xCellit workflow management and monitoring software system, a decentralised and automated manufacturing platform powered by Lonza’s Cocoon technology, and a quality control testing and release strategy.
GLPG5101 is an anti-cluster of differentiation 19 (CD19)/4-1BB CAR-T candidates, designed to be administered in a single fixed intravenous dose.
Galapagos is a biotech company with a presence in Europe and the US.
In December 2024, Galapagos shared additional data from the Phase I/II ATALANTA-1 study of GLPG5101, revealing a promising efficacy and safety profile in subjects with relapsed/refractory NHL.
Novo Holdings completed the previously announced acquisition of Catalent in a $16.5bn all-cash transaction in the same month.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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