Regardless of the type of cell therapy product or the medical indication, the production of cell-based therapeutics is highly complex. Minaris Regenerative Medicine offers you a comprehensive manufacturing experience that is fully compliant with the relevant regional regulatory requirements of our global facilities in North America, Europe, and Asia.
Learn more below about how our experts offer you a comprehensive manufacturing experience, fully compliant with the relevant regional regulatory requirements of our global facilities in North America, Europe, and Asia.
Whether you are looking ahead in anticipation of potential commercial production, should your product achieve the prerequisite regulatory approvals, or you have received such approval, Minaris Regenerative Medicine has commercial manufacturing capabilities and experience to serve your needs.
We have served the clinical manufacturing programs of more than 180 clients with cGMP Manufacturing (FDA guidelines) and GMP Manufacturing (EMA guidelines). Our team:
We help you advance through the phases of clinical development and optimize your manufacturing process toward commercial viability. Our GMP manufacturing capabilities include:
A technology transfer for cell therapy manufacturing is the transmission of knowledge, experience, specifications, procedures, and other critical data to another organization/facility, such as a contract development and manufacturing organization (CDMO), with the goal of establishing GMP-compliant manufacturing as needed for the respective clinical stage and regulatory environment (FDA, EMA, or PMDA).
Minaris Regenerative Medicine has performed more than 70 successful tech transfers for cell therapy products in different clinical trial phases through our systematic and strategic approach.
We do not claim ownership of the cell therapy product, or any of the IP needed to manufacture it.