Description
cGMP biobanks and repositories are designed to support human clinical-grade applications, including human cell and gene therapies, regenerative medicine, and other advanced therapeutic products. This level of biobanking is essential for ensuring that biological samples meet the safety, identity, purity, and potency standards required for clinical use. cGMP biobanking and biorepository services at Amnion Foundation are limited to human cells and tissues only.
Key features of cGMP biobanking at Amnion Foundation include:
-Rental space available in qualified and validated cryofreezers
-Storage in cGMP cryofreezer is available in multiple formats – cryovials,
bags, and other formats as needed
-Validated cryofreezer inventory system compliant with 21 CFR Part 11
regulation
-Redundant fail-over systems in place to ensure continual adherence to
cGMP procedures
-Real-time environmental monitoring of cryofreezer operation and
temperature
-Regularly scheduled audits of cryofreezer inventory by Quality Assurance
-Monthly reports of cryofreezer status provided
