Galapagos NV and Blood Centers of America (BCA) have entered into a strategic collaboration for the decentralized manufacturing of Galapagos’ CAR-T cell therapies through BCA’s network in the U.S.
 
Under the agreement, BCA will provide access to its network of more than 50 community blood centers in 43 states for Good Manufacturing Practice compliant manufacturing for Galapagos’ CAR-T hemato-oncology clinical program. This agreement complements existing collaborations between Galapagos and Landmark Bio and Thermo Fisher Scientific.
 
Galapagos will leverage BCA’s network to initiate technology transfer to multiple sites in parallel for the decentralized manufacturing of its CAR-T product candidates, close to cancer treatment centers, while also accessing apheresis capacity at BCA sites when required. BCA will also play a coordinating role by supporting site initiation and onboarding to accelerate Galapagos’ efforts and ensure consistent quality.
 
Galapagos’ decentralized manufacturing platform aims to address many of the limitations for currently available CAR-T production. It has the potential to offer greater speed and scalability, with the delivery of fresh, fit cells with a vein-to-vein time of seven days and the possibility for greater physician control and improved patient experience.
 
“Our collaboration with Blood Centers of America marks a major milestone for Galapagos’ U.S. expansion by establishing centers for support of our pivotal studies, with the potential to be used for commercial introduction. Working with BCA’s extensive nationwide network allows us to efficiently scale up decentralized CAR-T therapy manufacturing across the U.S., while their established infrastructure helps us harmonize operations and access apheresis capacity,” said Dr. Paul Stoffels1, CEO and Chairman of the Board of Directors of Galapagos. 

Galapagos platform consists of an end-to-end xCellit workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon®) and a proprietary quality control testing and release strategy.