Contract Development and Manufacturing Organizaton (CDMO)
In November 2014, Mithra laid the first stone of its future integrated R&D and manufacturing technological platform called Mithra CDMO. Two years later, on September 30th, 2016, Mithra celebrated the opening of this platform, specialized in polymeric forms, sterile injectables and hormonal tablets.
The strategic rationale for operating an in-house CDMO
- To be able to internally support the research and development of its product candidates and thereby keep its expertise in-house.
- To operate independently from third parties when developing and manufacturing its own therapeutic solutions using its own proprietary technology.
- To support projects from external companies for the development and production of polymeric forms, implants, sterile injectables and hormonal tablets.
Our integrated R&D and manufacturing platform forms an integral part of Mithra’s innovation and development strategy
Mithra CDMO is an open platform that operates as a unique pharmaceutical ecosystem covering drug development from proof of concept to commercialization.
It will support third parties willing to leverage our technological know-how and capabilities for the R&D and manufacturing of polymeric forms (intra-uterine systems, biocompatible rings, implants, (hydro)gels, sterile injectables (vials, ready-to-use cartridges, prefilled syringes) and hormonal tablets.
Mithra CDMO offers an integrated approach to pharmaceutical drug development : development, clinical supply manufacturing, stability studies, contract manufacturing, logistics & supply chain, quality assurance and regulatory services.
Stages of construction
2014 – 2016
- R&D facility and production lines for polymeric forms, implants and sterile injectables
- Inaugurated on September 30th, 2016