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Facility

Stempeutics operates two facilities located in Bangalore and Manipal, both in Karnataka, India.

Our Bangalore facility, is located in the 3rd floor of Manipal Hospitals Whitefield. Bangalore facility houses Clinical Team and General Administration. Manipal facility is dedicated to manufacturing of Stempeucel® product, quality assurance and quality control. Our Manipal facility has been the first facility in India to be approved for clinical trial & commercial manufacture for a stem cell product and is recommended for ISO 9001:2015 certification (from ISO 9001:2008).

Manipal GMP Facility

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.

Manipal facility has been approved by Indian Regulatory Authorities for Clinical Trial and Commercial Manufacturing (Received Form 29 and Form 28 from the regulatory authorities and the Quality system has been upgraded from ISO 9001:2008 to ISO 9001:2015).


BANGALORE OFFICE: 3RD FLOOR MANIPAL HOSPITALS WHITEFIELD



Clinical Team and General Admin is operated out of Bangalore Office