cGMP Facility

Description

Infrastructure/Methods

Gallery

Contact

The facility is designed to develop and manufacture cellular and tissue engineered products for clinical applications. It provides the infrastructure to conduct Phase I/II clinical trials by supporting translational medicine in the fields of cell therapy and regenerative medicine. The trained staff, directly interact with investigators and help in process development and manufacture of clinical grade products for use in early phase clinical trials.

Clinical grade cells manufactured

Bone Marrow derived Mesenchymal Stromal Cells (MSC)
No. of Samples Processed: 58
Total Cell yield: 6663.29 x 106 MSC
Placenta derived MSC
No. of Samples Processed: 7
Total Cell yield: 2458 x 106 MSC

Facility Layout

Approximately 1200 square feet, the clean room area is divided into four independent manufacturing suites and one common staging room which are all ISO Class 7 (Class 10,000). The manufacturing rooms have positive pressure to adjacent areas. Each suite is equipped with biological safety cabinet, CO2 Incubators, refrigerated high speed centrifuge and inverted phase contrast microscope.Also a one pass-through both sides is fitted to each room. The facility maintains unidirectional traffic flow for personnel and materials.

Services

There are four independent production suites capable of handling four different projects at a time. The following are the services provided by the GMP facility for users:

Provides clean-room suites for manufacture of clinical grade products under cGMP conditions forclinical applications.
Cryopreservation and storage of cell therapy products.
Bacterial Endotoxin testing using the Charles River EndosafePTS system.
Mycoplasma testing using ATCC universal mycoplasma detection kit.
Provides support in theregulatory approval process - Evaluate and interpret regulations and standards for cell based therapy from relevant agencies to determine its applicability to a PI’s clinical trial or study.

Facility Resources

Manufacturing Suites cleaned weekly (includes ceiling, wall, floor).
Change over cleaning between each manufacturing step.
Environmental Monitoring Program for both viable & non-viable contaminates- monthly.
Daily QC checks for door pressure, temperature, etc.

Current scientific activities

The cGMP facility was involved in the culture and expansion of autologous MSC for a clinical trial headed by Dr.VrishaMadhuri (Department of Paediatric Orthopaedics, CMC, Vellore), titled “Treatment of large segmental bone defects with custom made tri-phasic hydroxyapatite scaffolds loaded with mesenchymal stem cells in children”. Autologous clinical grade MSC is seeded on a synthetic scaffold and is allowed to differentiate into osteogenic cells. The scaffold with differentiated bone cells is transplanted to large segment defects and is monitored for natural bone formation. They have successfully transplanted the cell/scaffold product in remaining 5 patients with no report of any adverse reaction.

We are currently involved in the standardization of protocols under laboratory conditions and will be translated to GMP conditions in the future, for the following projects:

1. Gamma delta T cell-based immunotherapy for blood cancers. Centre for Stem Cell Research, CMC Campus and Department of Haematology, CMC.

2. Establishing a protocol for expansion of Natural Killer cells. Centre for Stem Cell Research, CMC Campus and Department of Haematology, CMC.

cGMP facility is also involved with the following research projects:

1. A study of human keloid fibroblasts in culture conditions and analyzing the effects of novel drugs on its progression. Department of Pharmacology, Clinical Pharmacology and Plastic Surgery unit, CMC and Centre for Stem CellResearch, CMC Campus.

A successful protocol was established for the isolation and culture of fibroblast from human skin.

2. Efficacy of Placenta derived Mesenchymal stem cells in reducing corneal scarring, in an ex-vivo organ culturemodel of post mortem human corneas. Department of Opthalmology, CMC and Centre for Stem Cell Research, CMC Campus.

An ex vivo organ culture model was established in which the human eye was maintained in sterile condition for a period of 28 days. This model will be used for further analysis by scientist from the department of ophthalmology.

Access

Access to the facility is limited only to GMP trained staff. The services are available for investigators from Christian Medical College, Vellore and other non-profit organizations. For any service related queries please contact Augustine Thambaiah at +91-416-307-5168 or e-mail cscrcpf@cmcvellore.ac.in