Manufacturing Services 

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. 


Commercial Manufacturing

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. 

  • Established state-of-the-art facilities in all regions with the systems and infrastructure needed to allow for commercial manufacturing.
  • Ability for late-stage products to seamlessly transition into commercial production at our facilities.
  • For clinical applications and commercial use in Europe, we offer release by a Qualified Person (QP) for products manufactured in the EU, as well as for products manufactured at our sites in the US or Japan for the European market.


Clinical Manufacturing


We have served the clinical manufacturing programs of more than 180 clients with cGMP Manufacturing (FDA guidelines) and GMP Manufacturing (EMA guidelines). Our team:

  • Listens to your needs
  • Learns your specific challenges and goals
  • Customizes a clinical manufacturing program for you to create a long-standing and trusting contract manufacturing partnership

We help you advance through the phases of clinical development and optimize your manufacturing process toward commercial viability. Our GMP manufacturing capabilities include:

  • Automating cell therapy manufacturing processes, including the Fill and Finish of the product. This allows us to create closed systems that enhance the efficiency and reliability of production and improve GMP compliance for the product.
  • Extensive experience with GMP manufacturing for Phase III trials. This helps clients advance towards reaching commercial manufacturing readiness, identifying issues that impact the quality, scalability, sustainability, and cost of goods for their cell therapy product and providing advice to overcome them.

Technology Transfer