On October 1, 2024 Excellos Inc., a cell therapy contract and development manufacturing organization (CDMO) member of Blood Centers of America (BCA), reported that it has been selected to manufacture Galapagos’ CAR-T cell therapy candidate, GLPG5101, for its recently FDA cleared ATALANTA-1 clinical study in patients with relapsed/refractory non-Hodgkin lymphoma in the U.S (Press release, Galapagos, OCT 1, 2024, View Source [SID1234646992]).
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Galapagos (Euronext & Nasdaq: GLPG) is a clinical stage biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life across the globe.
Excellos was selected upon completion of an extensive site audit and assessment process and will provide end-to-end manufacturing of Galapagos’ CAR-T cell therapy on Galapagos’ platform at Excellos’ new purpose-built manufacturing facility in downtown San Diego, CA.
Galapagos’ innovative, decentralized manufacturing platform could address many of the limitations that CAR-T cell therapy production is currently facing. It has the potential to offer greater speed and scalability, with the delivery of fresh, fit cells with a median vein-to-vein time of seven days and the possibility for greater physician control and improved patient experience.
"We are excited to manufacture Galapagos’ CAR-T cell therapy candidate using their decentralized manufacturing platform. This collaboration will enable the efficient production and delivery of fresh, fit CAR-T cell therapies within a median vein-to-vein time of seven days," said Thomas VanCott, CEO of Excellos. "Our team is proud to have demonstrated our agility in initiating technology transfer, our state-of-the-art facility, and our expertise in executing production and analytics, all of which are critical to advancing this groundbreaking therapy."
This project represents the first site initiation under the recently announced strategic collaboration between Galapagos’ U.S. entity GLPG US, Inc. and BCA. Under this agreement, BCA’s national network of blood centers will provide decentralized manufacturing services for Galapagos’ CAR-T cell therapy product candidates, close to cancer treatment centers across the U.S.
"Blood Centers of America is pleased to be actively engaged with Galapagos in site identification, assessment and initiation to build a nationwide decentralized cell therapy manufacturing network," stated Bill Block, President/CEO of BCA. "The Excellos project is enabled by the broader agreement between BCA and Galapagos which allowed Excellos to move efficiently from site assessment to the start of technology transfer. BCA will use the insights from this first initiation to accelerate the integration of multiple BCA sites into Galapagos’ decentralized manufacturing network, with the goal of providing patients convenient access to our local facilities and healthcare providers within their communities."