Cell Manufacturing

Cellex Cell Professionals offers a broad range of services for both clinical and research facilities in the field of cell therapy in a state-of-the-art GMP Facility, the Cellex Cell Manufacturing Plant (CCMP), as well as the GMP Training Center - both located in Cologne.

All employees are highly qualified and have extensive experience in the GMP-regulated environment. They are trained on regular base in all GMP-relevant areas to ensure the high standard of services and product quality for our customers.

Cellex has been cooperating closely with national and international partners for many years. The Cellex range of services also includes the import of cell therapy products into the European Union and distribution in the member states.

 

Manufacturing services

Magnetic Selection Cell separation Membrane Separation Cryopreservation Cultivation

Enrichment or depletion of different cell fractions using antibodies coupled with magnetobeads

Automated or manual separation of blood components using centrifugal force

Depletion of platelets 

Automated or manual dilution with cryomedia, controlled freezing

Automated cell processing, transfection and expansion

 All devices are operated using  functionally closed and sterile disposable kits. They are fully qualified and all methods are validated.

 

Quality Control

Flow Cytometry Cell Count Viability Blood Count

Analysis of different cell populations by determination of size, granularity and antigen expression on the cell surface using fluorescent labeled antibodies

Automatic quantification and analysis of cells using
impedance measurement

Determination of the number and percentage of viable cells using impedance measurement and staining Automated and rapid analysis of blood components

The quality control complies with the requirements of the current EU regulations, the ICH recommendations and the GMP guidelines. All devices are fully qualified and all methods are validated.

 

Cryo Storage

CCMP staff have expertise in cryopreservation and storage of cryopreserved products. Storage can take place at temperatures ≤ 140 ° C in vapor phase over liquid nitrogen in tanks with vacuum super insulation or at -80 ° C in freezers. An alarm system monitors the constant adherence to storage temperatures.