22/09/2025
https://www.facebook.com/share/p/17BQfA9Ehq/
All our preparations are produced in a GMP-compliant laboratory.
GMP (Good Manufacturing Practice) guidelines provide a quality assurance framework for manufacturing cell-based products intended for clinical use. Adhering to GMP ensures the identity, purity, potency, and overall quality of the final product.
Key Aspects of GMP Manufacturing
• Qualified Personnel – Staff must be properly trained in aseptic techniques, production processes, testing, documentation, and related procedures.
• Controlled Facilities – Cleanrooms, air filtration systems, gowning procedures, and other measures are used for contamination control.
• Validated Processes – Every production step must be scientifically demonstrated to consistently yield high-quality products.
• Raw Material Controls – Documented sourcing, verification of identity and purity, as well as proper storage and handling of all reagents and materials.
• Quality Control Testing – Comprehensive release testing for identity, purity, potency, sterility, endotoxins, and other quality parameters.
• Batch Documentation – Detailed records of each manufacturing batch to ensure full traceability.
• Deviation Management – Formal investigations and corrective actions are documented for any process deviations.
We value our patients and their outcomes, which is why we provide the highest-quality stem cell preparations to meet their needs.
