Inotech GMP Facility gets Swissmedic certificate for manufacturing of clinical products

Swiss based biotech company Inotech is proud to announce to having received health authority certificate (Swissmedic) for manufacturing of pharmaceutical products for clinical trials as well as for market supply (December 2004).
Within the up-to-date clean room GMP facility, Inotech provides services for aspectic filling and lyophilisation of pharmaceutical API and biopharmaceuticals. The automatic filling machine shows a capacity of 5'000 vials (10R) per hour and the lyophilisator enables a batch capacity of 6'000 vials (30R) up to 45'000 vials (2R). Inotech offers also manual filling and lyophilisation of bulk ware or of small vial batches, e.g. 500 ? 2'000 vials per batch. The service package includes development of filling and lyophilisation protocol, execution of test run and manufacturing of batches under cGMP conditions.
Additionally, Inotech shows services and facility for biotechnological GMP production of recombinant proteins made by mammalian cells and microbes (e.g. cytokines, hormones, monoclonal antibodies). Inotech service portfolio includes cell line development & vector constructing, process development and optimization, process validation, fermentation up to 200 L bioreactor, down-stream processes, validation of analytical methods, product filling, establishment of all relevant GMP documentation.
Inotech guarantees absolute confidential manufacturing. The Inotech core team consists of experts showing long-term experience in all relevant fields.