In order to address your unique global manufacturing and development needs, Minaris Regenerative Medicine has six state-of-the-art facilities across three different continents: North America (United States), Europe (Germany), and Asia (Japan).
Strategic alignment between our facilities allows for a seamless global manufacturing experience that mitigates risks, reduces your overall cost of goods, and supports the advancement of your therapeutic candidates to the market as well as commercial production for approved products.
Our global presence allows you to manufacture and deliver your therapeutic to patients worldwide, starting with access to North American, European, and Japanese markets.
Our capabilities, coupled with our talented scientists and biomedical engineers, are here to support you in every stage of your clinical manufacturing development and commercialization.
As a pioneer with more than 20 years’ experience providing outstanding quality and reliability, our facilities in the US, Europe, and Asia allow us to supply patients worldwide with life-changing therapies.
In our brochure, you will find:
All of our GMP manufacturing facilities offer cell and tissue cryogenic storage rooms with controlled access, live facility and equipment monitoring with automated alarm call-out, and UPS connection, ensuring the highest level of quality control and risk mitigation for product storage. In addition to CERs and cryostorage rooms, our facilities house GMP-compliant material management facilities, QC and analytical laboratories, as well as product and process development laboratories.
Our U.S. facilities hold all requisite licensures and maintain GMP-compliant quality systems
Our European facilities are compliant with all EU regulations and general FDA guidelines, hold all licenses for different types of complex cell and gene therapy products falling under the EU definition of Advanced Therapy Medicinal Products (ATMP).
Our Yokohama facility is compliant with Japanese GCTP regulations (PMDA) and is authorized to manufacture regenerative medicine products.
The future of cell and gene therapy production relies on our ability to fully meet the manufacturing needs of our existing and future clients. As an industry leader, we are always looking toward the future to expand our global facilities in order to enhance our capacity to serve you.