Stempeutics operates two facilities located in Bangalore and Manipal, both in Karnataka, India.
Our Bangalore facility, recognized by the Dept. of Scientific and Industrial Research, Govt. of India, houses general business as well as R&D activities whereas our Manipal facility is dedicated to production, quality assurance and control. Our Manipal facility has been the first facility in India to be approved for clinical trial manufacture for a stem cell product and is certified acc. to ISO 9001:2008.
Using a dedicated and segregate area associated with Manipal University, Stempeutics operates a 640 m2 aseptic manufacturing plant to serve clinical trials and commercial stage production.
To do so under state-of-the-art conditions, the entire operating area is provided with controlled air and production and quality control activities are segregated.
The production area follows the international clean room designation of grades D-A, the latter being the environment for open aseptic manipulations. Quality control activities are located in areas operated as D-C and, for further segregation, microbial and cell culture quality control activities are carried out in isolated grade C areas served by individual air handling/HEPA filtration systems; similarly, production areas are served by segregate air handling/HEPA units for the same purpose.
All classified areas as well as their surroundings are built acc. to clean room requirements and to withstand the rigors of frequent pharmaceutical cleaning using coved flooring and clean room panels for walls and ceilings; in combination, this provides for an operating environment optimized for quality.
In further alignment with Indian and internationally accepted guidelines the flow of goods is segregated from that of staff using active passboxes and air locks, respectively.
Our facility further harbors supervised cryogenic storage of its intermediate and final products using so-called vapor-phase storage – a refinement of cryogenic storage providing an extra measure of safety for patients.
Final product is shipped when required and cryogenic conditions are maintained during such shipments using sophisticated and validated shipping equipment. Consequently, Stempeutics is able to ship its products throughout the entirety of India while maintaining cryogenic cold chain conditions even under challenging ambient temperatures; this system also permits to ship our products globally.
While dedicated to R&D activities, our 700 m2 Bangalore facility also harbors a full-fledged clean room system with zones D-A served by independent air handling systems, air locks, pass boxes etc. This permits Stempeutics to develop processes under realistic conditions prior to transfer to the production plant. Additionally, it harbors facilities for cryogenic storage, R&D laboratories, non-classified cell culture rooms as well as pertinent supporting facilities.