Reproducibility and robustness of manufacturing processes are key requirements to ensure consistent quality of drugs. For biopharmaceuticals produced using genetically modified organisms, this means that it must be possible to provide the inoculum as a raw material and starting point for the production with consistent quality over the entire lifecycle of the product – potentially over a period of 30 years.
In order to provide our customers with another building block in biopharmaceutical development programs and (GMP) production campaigns, for preclinical and early clinical phases, we have developed processes, routines and documentation for the production of microbial Master Cell banks of 250 to 1000 vials in the Fraunhofer IME's cleanroom suite.
The manufacturing steps from clonalization via propagation to formulation and filling of the vials are carried out in a class C cleanroom. Selection and handling of raw materials and consumables and all manufacturing operations are treated and documented according to IME's GMP standards. All open handling steps are carried out in a biological safety bench under continuous particle monitoring. Freezing and storage is carried out in qualified equipment. Cell bank characterization can be carried out upon request.