Cellex Cell Professionals

Cellex Cell Professionals

CGT CDMO Cell Manufacturing Plant and Collection Center for Starting Materials

About the plant

Cellex is an end-to-end CDMO based in Cologne, Germany with over 10 years of experience in manufacturing autologous and allogeneic cell and gene therapy (CGT) products. We support customers from preclinical development through clinical manufacturing to commercialization. Currently, Cellex is manufacturing several final drug products (FDPs) and cellular intermediates (ITMs), including commercial products. 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 GDP-compliant logistics services for cellular materials.

Cellex is an end-to-end CDMO with deep expertise in manufacturing CGT products. With a track record of over 10 years, Cellex supports clients from preclinical development through clinical manufacturing to commercialization. Whether it is large biotechs, top 10 pharma companies, innovative start-ups, or academic institutions around the world, Cellex is your trusted partner.

• 50,000+ performed cell collections for CGT and SCT
• 10+ manufacturing licenses for autologous and allogeneic CGT
• Manufacturing of cellular intermediates and final drug products
• Involved in manufacturing 3 commercialized CAR-T therapies
• 5,000+ manufactured CGT batches
• >27,000 sq ft GMP manufacturing area
• 380+ Cellex experts working and growing together

CDMO Services for CGT

• Full GMP manufacturing service for autologous and allogeneic cell therapy products
• Cryopreservation and storage
• EU QP services
• Process development and optimization
• GDP-compliant supply chain and logistics

High-Quality Starting Materials

• Customized healthy and diseased donor materials
• Leukopaks, Mobilized Leukopaks, Cord Blood, Bone Marrow, Whole Blood
• Fresh and cryopreserved options
• For research, clinical, and commercial use
• Patient apheresis for sponsors

Consultancy Services

• Regulatory and GMP consulting
• Facility design and qualification support
• Technology transfer and process validation

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Certifications

• EMA (EU GMP)
• FDA (cGMP)

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Activity

• Cell therapy derivatives / Secretomes, ATMP (Advanced Therapies), FDF / DRUG PRODUCTS, BIOLOGICS, SERVICES manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• Toxicity (OEB classification): N/A
• DEA: N/A
• BSL: 1, 2
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU)

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, R&D, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Non sterile product manufacturing, Upstream, Tech transfer, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Labeling, Storage, CMC regulatory support

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