Catalent announces collaboration with Galapagos to further expand Galapagos’ Decentralized CAR-T Manufacturing Network
Catalent, Inc., a leader in enabling the development and supply of better treatments for patients worldwide, announced a strategic collaboration with Galapagos NV, a biotechnology company with operations in the U.S. and Europe, to support decentralized manufacturing for clinical studies of GLPG5101, Galapagos’ investigational CAR-T therapy for relapsed/refractory non-Hodgkin lymphoma (NHL) indications. Catalent’s commercial cell therapy manufacturing facility in Princeton, New Jersey, will support manufacturing for Galapagos’ upcoming trials in New Jersey, New York, and surrounding areas.
Galapagos’ innovative decentralized manufacturing platform for cell therapies is designed to be deployed close to cancer treatment centers. This class of therapies has shown promising results in patients with NHL, even those who have failed with other therapies.
By bringing the manufacturing process closer to patients, Galapagos’ platform has the potential to deliver fresh, fit, stem-like early memory cell therapy with a median vein-to-vein time of seven days, thereby avoiding cryopreservation and eliminating the need for bridging therapy.
Currently, all six approved CAR-T therapies are developed by four major pharmaceutical companies, and they all operate based on a centralised model because they’re used to it and have the capability.
A big pharmaceutical company can currently meet the demand with the centralised approach, using three different facilities. The issue lies primarily in the capacity of the approved treatment centres and the referral process. However, if the demand continues to rise as anticipated and if autologous cell therapies can potentially address other indications as well, it will be necessary to expand capacity and consider decentralisation. By distributing production facilities closer to the point of care, decentralised manufacturing enables personalised and on-demand cell therapies, hence fostering innovation, reducing logistical challenges, and ultimately improving patient outcomes.
The idea of IDMOs offers an attractive solution for smaller pharmaceutical and biotech companies that lack the capacity of larger established players. Their integrated and automated platform follows a scale-out approach, providing all the advantages required. Larger players, with more resources and expertise, can also adopt automated close technologies to speed up or decentralise their manufacturing process. Decentralisation is a potential model to improve the availability and speed of personalised therapies, such as CAR-T, to patients, especially considering the expected increase in demand.