cGMP STEM CELL FACILITY
KFRC has constructed the cGMP Stem Cell Facility under the department of regenerative medicine, a fully validated facility designed for the processing of autologous stem cell and its subsequent application in various clinical studies. It is a key component of the Regenerative Medicine and intends to serve as a resource for both research and clinical studies. Stem cell facility is designed as a multi-use cGMP manufacturing and testing facility with the goal of accelerating clinical studies with the following capabilities:
- Development of clinical-scale manufacturing processes
- Development of analytical methods for product characterization and release
- GMP manufacturing and in-process testing of clinical-grade materials
- Quality control release testing of final product
- Management of external CRO’s providing additional testing and services
- Quality control release of final product
- cGMP or Current Good Manufacturing Practices refers to the CDSCO Code of Regulations which requires that products intended for human use are safe, pure, and effective.
- GMP regulations and guidance provide for a “Quality Approach” to manufacturing and testing with the goal of eliminating or minimizing contamination, cross-contamination, mix-ups, and errors in order to protect human patients.