Manufacturing Technology

From our conception, Innovacell has adhered to the highest international quality standards for decades while developing a viable methodology for the production of cell therapy products.

For Innovacell, maintaining quality and safety is of the utmost importance - within manufacturing we always pay the greatest attention to product quality management. To meet our exacting standards, we have built out our own manufacturing system equipped with commercial-scale production capabilities.

Establishing diverse cell manufacturing processes continues to be a fundamental challenge in the fields of medicine and life sciences, requiring extensive expertise in a vast array of scientific fields. The cells that we have manufactured to date include a wide variety of cell types including skeletal muscle, connective tissue, dendritic, and hair follicle cells.

Innovacell brings deep regulatory expertise to every stage of cell therapy development. With years of experience conducting multinational, multicenter clinical trials across Phases I, II, and III, we operate in full compliance with Good Clinical Practice (GCP) standards. Our validated protocols for cross-border biopsy handling and cell transport ensure seamless execution across international sites.

We have a proven track record of successful regulatory interactions with major health authorities, including the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). These engagements reflect our ability to navigate complex approval pathways and accelerate the global commercialization of innovative therapies.