About the Upstate Stem Cell cGMP Facility
What is a CGMP Facility?
cGMP (current Good Manufacturing Practice) refers to the FDA Good Manufacturing Practice Regulations requiring that products intended for human use are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, intended to minimize or eliminate contamination, mix-ups, and errors in order to protect patients from ineffective or dangerous products.
hESC-derived Neural Stem Cell rosettes
(stained with Sox1)
Photo courtesy of Chris Proschel (URMC)
The focus of this facility is to establish a cell-based GMP program to support stem cell research in Upstate New York by providing specialized laboratories for the production and testing of cGMP-grade products in order to accelerate first-in-human human applications of stem cell research.
In addition, the staff will provide training opportunities in GMP compliance, manufacturing, validation, Quality Assurance and Quality Control, as well as provide expert guidance on regulatory requirements, and interactions with government agencies.
The University of Rochester hopes to promote and facilitate collaboration among stem cell scientists throughout Upstate New York, and their colleagues/collaborators at other institutions.
Our Guiding Principles
- Adherence to GMP regulations as required by the FDA for the production of Phase 1 clinical trial materials.
- Establishment of a GMP compliant Quality System ensuring completeness of documentation, document control, validation, personnel training, change control.
- Maintenance of a Quality Control function for environmental monitoring and release testing of clinical trial materials.
- Maintenance of a Quality Assurance function to ensure GMP compliant manufacturing, testing, and release of clinical trial materials as well as audit readiness.
- Use of qualified vendors as suppliers of raw materials and reagents used in manufacturing and testing.