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.
The start to an exciting manufacturing process. We have successfully executed more than 70 tech transfers for cell therapy products and have a systematic and strategic approach to ensure high quality.
We create a customized, fully compliant clinical manufacturing program in accordance with FDA and EMA guidelines. By listening to your specific needs and challenges, our team will advance your product to commercial readiness.
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: