Shared Facilities » cGMP

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 cscrcpf@cmcvellore.ac.in

Design

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.

Features

The CSCR GMP facility hosts a range of state-of-the-art equipments for the production and storage of clinical grade cells.

Equipments

  • Each suite is equipped with two CO2 incubators, a laminar flow hood, a refrigerated centrifuge and an inverted microscope.
  • The common staging area has - 20C and -80C freezers as well as equipment for controlled rate freezing and a laminar air flow hood.
  • The other equipments inside the GMP facility include a shaker incubator, liquid aspiration station & water bath.

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.

Ongoing Work

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)

Quality Control

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)

Quality Assurance

Meticulous documentation of every step involved in the manufacture process, validation, stocks and release of final product

SOP generation

Equipment maintenance

Audits

On Going Projects   On Going Projects

Contact Us


Dr. Vikram Mathews,

Professor, Department of Haematology,
Christian Medical College,
is the Facility In-Charge of the GMP facility.


Mr. Augustine Thambaiah,

Technical Officer, Centre for Stem Cell Research.


Ms. Aleya Tabasum

Technician, Centre for Stem Cell Research.

Email: cscrcpf@cmcvellore.ac.in
Phone: 0416-307-5168/4101