Cellex Expands GMP Manufacturing Capacity Following Production of Over 5,800 Cell and Gene Therapy Batches
核心洞察
Cellex Cell Professionals (搜索) announces major facility expansion, now operating over 2,500 m² of GMP-certified manufacturing area with 43% allocated to cleanroom operations across 37 workstations.
The German CDMO has manufactured more than 5,800 CGT/ATMP batches including 1,300+ clinical and 4,500+ commercial products, supporting three EU-approved CAR-T (搜索) therapies.
In 2023, Cellex successfully manufactured Europe's first allogeneic CAR-T (搜索) product, demonstrating its capabilities in cutting-edge cellular therapy development.
Cellex Cell Professionals (搜索), a leading European contract development and manufacturing organization (CDMO) specializing in cell and gene therapy (CGT), has announced a major expansion of its GMP manufacturing facilities following the successful production of over 5,800 CGT/ATMP batches. The milestone underscores the company's growing role in supporting the commercial production of advanced cellular therapies across Europe.
Facility Expansion Supports Growing Demand
The Cologne-based CDMO now operates over 2,500 m² (over 27,000 ft²) of GMP-certified manufacturing area, with 43% allocated to cleanroom operations across 37 workstations. This expansion represents the culmination of three major infrastructure upgrades undertaken since 2019, integrating high-throughput cleanroom environments and quality control laboratories.
"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."
Commercial Manufacturing Track Record
Cellex has demonstrated consistent execution across the full development spectrum, manufacturing more than 5,800 CGT/ATMP batches including 1,300+ clinical and 4,500+ commercial products. The company currently manufactures six final drug products and seven cellular intermediates, supporting the commercial production of three CAR-T (搜索) therapies approved in the European Union.
A significant milestone came in 2023 when Cellex successfully manufactured Europe's first allogeneic CAR-T (搜索) product, reinforcing its role in cutting-edge therapy development. The company's manufacturing capabilities span both autologous and allogeneic cell therapies, positioning it uniquely among European CDMOs.
Established Partnerships and Growth Pipeline
Long-standing partnerships underscore Cellex's credibility and manufacturing maturity. The company's collaboration with its first pharmaceutical client began in 2017, with the first commercial batch delivered in 2023. Work with a second pharmaceutical client started in 2020, followed by the first commercial delivery in 2024.
In January 2025, Cellex onboarded two new clients, with a robust pipeline of new mandates planned for the remainder of the year and beyond. The company has also launched a new materials warehouse designed to the highest standards, ensuring quality, safety, and efficiency for every batch with expanded storage capacity.
Comprehensive Service Portfolio
Founded in 2001 in Dresden by Prof. Dr. Gerhard Ehninger to secure sourcing of cellular therapies for patients requiring allogeneic blood stem cell transplantation (搜索), Cellex has evolved into a comprehensive service provider. The company has performed over 50,000 cell collections since expanding to Cologne in 2009 and has ensured reliable global transport of more than 20,000 cellular shipments.
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 including Leukopaks, Mobilized Leukopaks, Whole Blood, and Bone Marrow. The company entered the CGT manufacturing field in 2014 by launching its first preclinical and clinical development program focused on adapter CAR-T (搜索) technology.