The 4600 sq.ft Current Good Manufacturing Practice (cGMP) Facility is located at the CSCR campus, adjacent to the main building. The four functional ISO class 7 cell producation suites, equipped with state-of-the-art equipment and fitted with stainless steel furniture, will make it easaier for researchers to engineer and manipulate cells for use in a variety of new treatment. The central HVAC air handling unit that is located above the clean rooms, helps to maintain the air quality inside the facility by providing thermal comfort and also by adequate ventilation with filtration. The floors are finished with a highly durable vinyl coating to maintain high level of cleanliness.
The centre plans to make facility's services available to other institutions across the country. For enquiries about the availability of the cGMP facility for the manufacture of Clinical Grade cells, please contact Mr. Augustine Thambaiah at firstname.lastname@example.org
GMP suites - Currently, there are four functional GMP suites of about 200 sq. ft each leading into a common staging area. A liquid nitrogen generation plant and a cryopreservation room is situated adjacent to the facility.
The CSCR GMP facility hosts a range of state-of-the-art equipments for the production and storage of clinical grade cells.
Liquid Nitrogen Plant
Liquid nitrogen plant - A on-site liquid nitrogen plant (Stirling Stir Lin-1 Economy) capable of providing up to 120 liters per day (~5 litres/hour) connected to a 200 litre cylinder (WESSINGTON Cryogenics PV200S) for collection and storage, is situated adjacent to the GMP facility.
Cryopreservation and Storage
Facility for cryopreservation and long term storage is within the GMP facility and is equipped with two storage containers (MVE CRYOCYL 230LP & Statebourne Cryostar 300) each connected to a 230 liters self filling liquid nitrogen tank (Wessington Cryogenics-PV200S) & two dry shippers (MVE Cryoshipper) for the transport of samples andcells.
Isolation, culture, expansion and cryopreservation of clinical grade bone marrow and placenta derived Mesenchymal Stromal Cells.
Autologous cultured chondrocytes from iliac crest in the treatment of physeal bars in children - A pilot study.
Human platelet lysate as a substitute for fetal bovine serum in the culture and expansion of bone marrow derived mesenchymal stromal cells. (Fluid Research Grants)
It includes in process control and final product characterization (e.g. sterility testing & surface marker analysis by flow cytometry)
The in-house quality control test for Sterility Testing include:
• ENDOSAFE PTS - for Endotoxin testing
• Mycoplasma PCR - for Mycoplasma testing
• Air Sampling - for Particle count
• Fallout Plate - for Viable particle (Bacteria & Fungi)
• Meticulous documentation of every step involved in the manufacture process, validation, stocks and release of final product
• SOP generation
• Equipment maintenance
Professor, Department of Haematology,
Christian Medical College,
is the Facility In-Charge of the GMP facility.
Technical Officer, Centre for Stem Cell Research.
Technician, Centre for Stem Cell Research.