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Comunicato stampa - Responsabilità editoriale PrNewswire

A Decade of Cell & Gene Therapy Manufacturing and Major GMP Facility Expansion: Cellex's Track Record of Scalable Excellence

10 giugno 2025 | 14.00
LETTURA: 3 minuti

Facility expansions and over 5,800 CGT/ATMP batches manufactured underscore Cellex's strength as a trusted full-service CDMO in Europe.

COLOGNE, Germany, June 10, 2025 /PRNewswire/ -- Cellex Cell Professionals (Cellex), a full-service Contract Development and Manufacturing Organization (CDMO) with 10+ years of experience in Cell & Gene Therapy (CGT), announces facility expansion and reflects on a series of milestones that have shaped its position as a trusted partner in CGT/ATMP manufacturing. With strategic facility expansions, groundbreaking collaborations, and a proven clinical and commercial record of accomplishment, the company continues to solidify its leadership within the European CGT sector.

 

A Legacy Built on Purpose and Growth

Founded in 2001 in Dresden by Prof. Dr. Gerhard Ehninger to secure sourcing of cellular therapies for patients in need of an allogeneic blood stem cell transplantation, Cellex has grown into one of Europe's leading CGT CDMOs, driven by a strong focus on patient access and operational excellence. In 2009, Cellex expanded to Cologne by opening a second collection center. Since then, the team performed over 50,000 cell collections.

By 2013, the company extended its services to cover the entire value chain, ensuring reliable global transport of more than 20,000 cellular shipments to date - further establishing its end-to-end manufacturing capability.

Since 2018, Cellex has supported the CGT supply chain with a donor database for R&D, clinical trials, and commercial programs, supplying GMP-grade starting materials such as Leukopaks, Mobilized Leukopaks, Whole Blood, and Bone Marrow.

Cellex Announces Major Facility Expansion and Operational Milestones

From 2019 onward, Cellex undertook three major expansions of its GMP infrastructure, integrating high-throughput cleanroom environments and quality control labs. With the latest facility expansion, the company operates over 2,500 m² (over 27,000 ft²) of GMP-certified manufacturing area, with 43% allocated to cleanroom operations across 37 workstations.

With more than 5,800 CGT/ATMP batches manufactured - including 1,300+ clinical and 4,500+ commercial products - Cellex has demonstrated consistent execution across the full development spectrum. The company currently manufactures six final drug products and seven cellular intermediates, and supports the commercial production of three CAR-T therapies approved in the EU. In 2023, Cellex successfully manufactured Europe'sfirst allogeneic CAR-T product, reinforcing its role in cutting-edge therapy development.

"In the manufacturing of advanced therapies, innovation must be matched by a high degree of precision and reliability." says Carla Kreissig, Managing Director and Chief Medical Officer of Cellex. "Reaching over 5,800 batches reflects not just scale - but deep process maturity and trust from our partners. With our latest GMP facility expansion, we are further strengthening our capabilities to meet growing demand and ensure continued excellence."

Additionally, a new materials warehouse was launched this year. Designed to the highest standards, it ensures quality, safety, and efficiency for every batch. With expanded storage capacity, we are well equipped to meet the continuously growing demand in CGT manufacturing.

From Early Innovation to Scalable CGT Manufacturing

In 2014, Cellex entered the CGT field by launching its first preclinical and clinical development program focused on adapter CAR-T technology in Dresden. A dedicated manufacturing facility was established in Cologne to support PoC trials for academic and biotech partners.

Long-standing partnerships underscore the company's credibility and manufacturing maturity:

Looking Ahead: Growth, Pipeline, and Commitment

In January 2025, Cellex Cell Professionals onboarded two new clients, with a robust pipeline of new mandates for the remainder of the year and beyond. With over 10 years of experience in autologous and allogeneic cell therapy and the ability to support clients from preclinical phases through to commercial launch, Cellex Cell Professionals remains uniquely positioned among European CDMOs - defined not by capability alone, but by a proven record of execution.

About Cellex Cell Professionals

Cellex Cell Professionals is a leading, full service CDMO specializing in CGT. With its state-of-the-art facilities located in Cologne, Germany, and a proven track record of 10+ years in GMP-compliant autologous and allogeneic cell therapy manufacturing, Cellex is partnered with several major pharma and innovative biotech companies supporting their process development and clinical and commercial manufacturing. In addition, Cellex offers customized starting materials from healthy donors and patients affected by specific conditions for research, clinical and commercial purposes as well as storage and logistics services.

Learn more at www.cellex.me/en.

Media ContactPhone: +49 221 2509 0E-mail: infocenter@cellex.me

Logo: https://mma.prnewswire.com/media/2621986/5352785/Cellex_Logo.jpg

View original content:https://www.prnewswire.co.uk/news-releases/a-decade-of-cell--gene-therapy-manufacturing-and-major-gmp-facility-expansion-cellexs-track-record-of-scalable-excellence-302473126.html

Comunicato stampa - Responsabilità editoriale PrNewswire

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