The completion of protocols for advanced therapies, tissue engineering and the development of the related clinical studies, must take place in environments classified under directives UNI EN ISO and cGMP, and as such is considered equivalent, to all effects and purposes, to the production of traditional pharmaceuticals.
SOL offers a complete service for the design, construction, management and maintenance of positive pressure (Cell Factory, Clean Room) or negative pressure (BL) cGMP laboratories for the handling and production of cells, tissues, organs, biological pharmaceuticals and active principles.
The SOL Cell Management service consists of the following separate modules:
- laboratory design
- structure and plant construction
- supply of apparatus and consumables
- cGMP validation of the structure and revalidation
- software for working with and managing biological samples
- facility maintenance and training courses