Excellos Selected as Decentralized Manufacturing Unit to Support Galapagos’ CAR-T Cell Therapy Clinical Study Close to Cancer Treatment Centers in the San Diego Area
Excellos Inc., a cell therapy CDMO member of Blood Centers of America (BCA), has been selected to manufacture Galapagos' CAR-T cell therapy candidate, GLPG5101, for its FDA-cleared ATALANTA-1 clinical study in patients with relapsed/refractory non-Hodgkin lymphoma in the U.S. Excellos will provide end-to-end manufacturing at its new facility in San Diego, CA, using Galapagos' innovative, decentralized manufacturing platform.
This platform aims to address limitations in CAR-T cell therapy production, offering greater speed and scalability with a median vein-to-vein time of seven days. The collaboration is part of a strategic agreement between Galapagos' U.S. entity and BCA, which will provide decentralized manufacturing services for Galapagos' CAR-T cell therapy candidates across the U.S., close to cancer treatment centers.
Excellos Inc., un membro CDMO della terapia cellulare dei Blood Centers of America (BCA), è stata selezionata per produrre il candidato alla terapia cellulare CAR-T di Galapagos, GLPG5101, per il suo studio clinico ATALANTA-1 approvato dalla FDA, rivolto a pazienti con linfoma non-Hodgkin recidivante/resistente negli Stati Uniti. Excellos fornirà una produzione completa presso la sua nuova struttura a San Diego, CA, utilizzando l'innovativa piattaforma di produzione decentralizzata di Galapagos.
Questa piattaforma mira a superare le limitazioni nella produzione della terapia cellulare CAR-T, offrendo maggiore velocità e scalabilità con un tempo mediano da vena a vena di sette giorni. La collaborazione fa parte di un accordo strategico tra la divisione statunitense di Galapagos e BCA, che fornirà servizi di produzione decentralizzata per i candidati alla terapia cellulare CAR-T di Galapagos in tutta l'America, vicino ai centri di trattamento oncologico.
Excellos Inc., un miembro CDMO de terapia celular de los Blood Centers of America (BCA), ha sido seleccionada para fabricar el candidato a terapia celular CAR-T de Galapagos, GLPG5101, para su estudio clínico ATALANTA-1 aprobado por la FDA en pacientes con linfoma no-Hodgkin recidivante/refractario en los EE. UU. Excellos ofrecerá fabricación integral en su nueva instalación en San Diego, CA, utilizando la innovadora plataforma de fabricación descentralizada de Galapagos.
Esta plataforma tiene como objetivo abordar las limitaciones en la producción de terapia celular CAR-T, ofreciendo mayor rapidez y escalabilidad con un tiempo medio de vena a vena de siete días. La colaboración es parte de un acuerdo estratégico entre la entidad estadounidense de Galapagos y BCA, que proporcionará servicios de fabricación descentralizada para los candidatos a terapia celular CAR-T de Galapagos en todo EE. UU., cerca de los centros de tratamiento de cáncer.
Excellos Inc.는 Blood Centers of America(BCA)의 세포 치료 CDMO 회원으로, 갈라파고스의 CAR-T 세포 치료 후보인 GLPG5101을 제조하기 위해 선정되었습니다. 이 제품은 미국 내 재발성/불응성 비호지킨 림프종 환자를 대상으로 하는 FDA 승인 ATALANTA-1 임상 연구에 사용됩니다. Excellos는 샌디에이고, CA에 있는 새로운 시설에서 갈라파고스의 혁신적인 분산 제조 플랫폼을 사용하여 턴키 제조를 제공합니다.
이 플랫폼은 CAR-T 세포 치료 생산의 한계를 해결하는 것을 목표로 하며, 정맥에서 정맥까지의 중간 시간 7일 동안 더 빠르고 확장 가능한 생산을 제공합니다. 이 협력은 갈라파고스의 미국 지사와 BCA 간의 전략적 협정의 일환으로, 미국 전역의 암 치료 센터 인근에서 갈라파고스의 CAR-T 세포 치료 후보를 위한 분산 제조 서비스를 제공할 것입니다.
Excellos Inc., membre CDMO de thérapie cellulaire des Blood Centers of America (BCA), a été séléctionnée pour fabriquer le candidat à la thérapie cellulaire CAR-T de Galapagos, GLPG5101, pour son étude clinique ATALANTA-1 approuvée par la FDA portant sur des patients atteints de lymphome non-Hodgkin récurrent/réfractaire aux États-Unis. Excellos fournira une fabrication de bout en bout dans sa nouvelle installation à San Diego, CA, utilisant la plateforme de fabrication décentralisée innovante de Galapagos.
Cette plateforme vise à surmonter les limitations dans la production de thérapies cellulaires CAR-T, offrant une plus grande rapidité et évolutivité avec un temps moyen de sept jours entre les veines. La collaboration fait partie d'un accord stratégique entre l'entité américaine de Galapagos et le BCA, qui fournira des services de fabrication décentralisée pour les candidats à la thérapie cellulaire CAR-T de Galapagos à travers les États-Unis, près des centres de traitement du cancer.
Excellos Inc., ein CDMO-Mitglied der Zelltherapie der Blood Centers of America (BCA), wurde ausgewählt, um den CAR-T-Zelltherapiekandidaten GLPG5101 von Galapagos herzustellen, für dessen von der FDA genehmigte klinische Studie ATALANTA-1 bei Patienten mit rezidivierendem/refraktärem Non-Hodgkin-Lymphom in den USA. Excellos wird eine umfassende Herstellung in seiner neuen Einrichtung in San Diego, CA, anbieten, unter Verwendung von Galapagos' innovativer dezentraler Produktionsplattform.
Diese Plattform zielt darauf ab, die Einschränkungen in der Produktion von CAR-T-Zelltherapien zu überwinden und bietet eine größere Geschwindigkeit und Skalierbarkeit mit einer mittleren Zeit von Vene zu Vene von sieben Tagen. Die Zusammenarbeit ist Teil einer strategischen Vereinbarung zwischen der US-Einheit von Galapagos und BCA, die dezentrale Produktionsdienstleistungen für die CAR-T-Zelltherapiekandidaten von Galapagos in den USA, nahe den Krebsbehandlungszentren, bereitstellt.
- Excellos selected as the first decentralized manufacturing unit for Galapagos' CAR-T cell therapy
- Potential for faster and more scalable CAR-T cell therapy production with a median vein-to-vein time of 7 days
- Strategic collaboration with Blood Centers of America for nationwide decentralized manufacturing network
- None.
Insights
Galapagos' selection of Excellos as a decentralized manufacturing unit (DMU) for their CAR-T cell therapy is a significant development in the field of cancer treatment. This collaboration aims to address key challenges in CAR-T production, potentially offering:
- Faster manufacturing with a median vein-to-vein time of 7 days
- Improved scalability and fresh, fit cell delivery
- Greater physician control and enhanced patient experience
The decentralized approach, leveraging Blood Centers of America's network, could revolutionize CAR-T therapy accessibility. However, it's important to note that GLPG5101 is still in clinical trials for relapsed/refractory non-Hodgkin lymphoma and success is not guaranteed. This partnership demonstrates Galapagos' commitment to innovation in cell therapy manufacturing, potentially positioning them as a leader in the competitive CAR-T market if successful.
This partnership between Galapagos and Excellos represents a strategic move in the CAR-T therapy landscape. Key points to consider:
- Decentralized manufacturing could significantly reduce production costs and time, addressing major hurdles in CAR-T commercialization
- The collaboration with Blood Centers of America provides Galapagos with a potential nationwide manufacturing network, offering a competitive edge in market reach
- If successful, this model could attract partnerships with other biotech firms, potentially generating additional revenue streams for Galapagos
However, investors should be cautious. The success of this approach depends on the clinical efficacy of GLPG5101 and the seamless execution of the decentralized manufacturing process. Regulatory approval for this novel manufacturing method will also be crucial. While promising, this development is still in its early stages and its full impact on Galapagos' financial performance remains to be seen.
Excellos is the first decentralized manufacturing unit (DMU) within the nationwide network of Blood Centers of America to be selected for Good Manufacturing Compliant (GMP) manufacturing for Galapagos’ CAR-T hemato-oncology program.
Galapagos (Euronext & Nasdaq: GLPG) is a clinical stage biotechnology company with operations in
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
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’
“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.”
About Excellos
Excellos provides custom cGMP services to develop and manufacture cell therapies. Featuring proprietary cell characterization technologies, Excellos reduces variabilities in clinical responses and increases the probability of successful outcomes. Current applications support TIL-based therapies, autologous and allogeneic CAR-T/NK therapies and TCR therapies. Customized services include donor recruitment, cell isolation, transduction, expansion and scale up GMP production. Learn more at www.excellos.com.
About Galapagos
Galapagos is a biotechnology company with operations in
About BCA Advanced Therapies Network
The Blood Centers of America (BCA) Advanced Therapies Network leverages the largest blood supply network in
Contact us to learn more about how Excellos can help you manufacture your cells.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241001953385/en/
Marianne Woodard
Brainspores
408 313 8583
Marianne.woodard@Brainspores.com
Source: Excellos Inc.
FAQ
What is the purpose of Galapagos' ATALANTA-1 clinical study for GLPG5101?
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What is the significance of Excellos being selected as a decentralized manufacturing unit for Galapagos (GLPG)?
How might the collaboration between Galapagos (GLPG) and Blood Centers of America impact CAR-T cell therapy accessibility?
