Our cGMP facility offers globally harmonized GMP-compliant cell therapy manufacturing infrastructure with controlled flow of personnel and materials and environmental monitoring, ensuring the highest level of quality control and risk mitigation for product manufacturing. Features of our clean room include:
This stringent compliance with cGMP and cGTP regulations ensures the identity, strength, quality, and purity of our mesenchymal stem cell product.
It turns out that MSC’s are very responsive to their environment. In a lab-based manufacturing process, MSC’s are exposed to an environment very different from the body – one that could change the way they respond to growth factors and one that could result in MSC preparations with lots of unexpected, and undesirable, individualism.
Former Chief of the FDA’s Cellular and Tissues Therapy Branch Division of Cellular and Genetherapies
Our proprietary state-of-the-art process is designed to ensure the fidelity of our cells in that the nMSCs are not changed or altered during processing to maintain their native architecture:
The system breaks down the fat cells through kinetic energy generated by high-frequency, gentle vibration (up to 5,000 strokes/min with a stroke length of 2.8 mm), removes the fat cells with a gentle suction process and captures the undamaged adipose cells.
To allow us to treat patients during the same surgical procedure, our state-of-the-art ISO 7 clean-room is an integral part of our processing room design.
Keeping the micro‐architecture of the adipose cells (fat) intact, by physical fragmentation into sub‐millimetric units, the system provides for optimal maintenance of regenerative cells and dramatically improves factor secretion thereby.
