Facilities
Apceth operates within state-of-the-art facilities which provide a unique combination of GMP and S2 laboratories. The manufacturing of the stem cell products is performed within Cleanroom suites of class C and B with a class A area.
The Apceth Cleanrooms are used for handling, cultivation and modification of stem cells according to the highest technological and quality standards. The Cleanrooms are accompanied by separate quality control (QC) laboratories. The Apceth core Cleanroom, GMP/QC and R&D laboratories are located in Munich-Großhadern. Additional GMP-facilities, which comprise four separate Cleanrooms class B/A and class C and QC laboratories, are currently being equipped at the location Munich-Ottobrunn. These new GMP-facilities will be available for manufacturing in the first half of 2011. Together with the core GMP-facilities, this will extend Apceth Cleanroom area to 600 m2 comprising five separate Cleanroom suites.
The Quality Control Unit is an essential element within Apceth facilities to which particular attention is paid. Each step of the manufacturing process is strictly controlled and carefully documented. This allows control over the final product and traceability of the production procedure.
The Apceth cell products are cryopreserved under rigorously monitored and highly optimized conditions in a 24/7 supervised cryofacility before their final distribution to the clinical centers for the purpose of therapeutic application.
Apceth facilities are generously equipped to satisfy the highest technological and methodological standards currently available in the fields of molecular and cell biology, immunology and cell culture. The broad spectrum of Apceth’s methods encompasses also all aspects of Quality Control of unmodified and genetically modified cell products. The Quality Control methods and potency assays are all developed, validated and established in-house. Analysis of genetic stability, gene expression profiling and donor testing are performed in cooperation with certified contract partners, to further ensure the product quality.