Fette Compacting and CMIC CMO USA, a Contract Development and Manufacturing Organisation (CDMO), are entering into a strategic cooperation.
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The partnership marks a milestone in the implementation of Fette Compacting's new strategy “Together - from lab to production” and strengthens the company's position as a holistic process partner.
At the center of the collaboration is the integration of the FE CPS Continuous Direct Compression system with a FE55 rotary tablet press from Fette Compacting into CMIC's GMP-certified cleanrooms in Cranbury, New Jersey. With the help of Fette Compacting and CMIC, pharmaceutical companies can develop and validate Continuous Manufacturing processes and have clinical samples produced under regulated conditions. The combination of CMIC's regulatory expertise and Fette Compacting's technological leadership creates a unique development platform.
“As a tableting specialist, we are consistently developing into a process partner for the entire powder formulation and tablet production process,” explains Joachim Dittrich, CEO of Fette Compacting. "The cooperation with CMIC is an important step in this direction. Together, we support pharmaceutical manufacturers from early development onwards - with the aim of bringing innovative medicines to market faster and more efficiently."
Key technologies bundled in one place
The partnership bundles innovative systems for the entire development process: Fette Compacting's F Lab series, for example, supports formulation development by precisely characterising powder properties and tablets. Special emulators enable the testing of process parameters under real conditions with minimal use of materials. The FE CPS forms the heart of Continuous Production, while the embedded process analysis technology (ePAT) monitors critical parameters in real time - from dosing and powder mixing to the finished tablet.
Complementary skills
The partnership combines complementary strengths: Fette Compacting contributes its process engineering expertise and technology leadership in tableting while CMIC has many years of experience in GMP-compliant development and production of clinical supplies, and commercial products with broad analytical laboratory capabilities.
“This partnership opens up completely new opportunities for our customers, not just in the US market,” said Ulrik Frodermann, president of Fette Compacting America. "The integration of the FE CPS into CMIC's cleanrooms enables pharmaceutical companies for the first time to advance their formulation development in parallel to building their own production capacities. Fette Compacting's approach simplifies the entire development and validation process: customers benefit from short distances and the seamless combination of formulation development and analytical studies in one location."
“We are excited to further our vision as a CDMO of choice through this partnership with Fette Compacting,” said Takahiro Ueda, CEO of CMIC CMO USA. "The innovative process technology will significantly increase speed and flexibility in the development and manufacture of oral dosage forms. The synergy between Fette Compacting's advanced solutions and our CDMO expertise exposes new possibilities for modern formulations and more efficient manufacturing methods. Ultimately, the patients who rely on these therapies will benefit."
Premiere in June 2025
The new development platform will be presented to a trade audience for the first time at a joint event on June 3, 2025. In the long term, both partners plan to systematically expand their collaboration with the aim of establishing a comprehensive service portfolio.