Fette Compacting and CDMO "CMIC CMO USA" are entering into a strategic partnership. The collaboration is an important step in the implementation of Fette Compacting's new strategy, “Together - from lab to production.” It strengthens the company's position as a comprehensive process partner. The focus of the collaboration is the integration of the “FE CPS” continuous direct compression system with an “FE55” rotary tablet press into CMIC's GMP-certified cleanrooms in Cranbury, New Jersey. There, pharmaceutical companies can now develop and validate continuous manufacturing processes and have clinical samples produced under controlled 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 from Fette Compacting bundled in one place
The partnership will see innovative systems for the entire development process being bundled together. Fette's “F Lab” series supports formulation development by precisely characterizing powder properties and tablets. Special emulators enable process parameters to be tested under real conditions with minimal material usage. The "FE CPS" forms the heart of continuous production. Integrated process analysis technology (ePAT) monitors critical parameters in real time, from dosing and powder mixing to the finished tablet.
GMP-compliant development and production of clinical samples and commercial active ingredients
Fette Compacting contributes its process engineering expertise and technological leadership in tableting to the cooperation. In addition, CMIC has many years of experience in the GMP-compliant development and production. This includes clinical samples and commercial products with comprehensive analytical laboratory capacities. The two manufacturers thus combine complementary strengths.
Advancing formulation development in parallel with the expansion of in-house production capacities
“This partnership opens up completely new opportunities for our customers, not just in the US market,” emphasizes 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."
Launch: Fette Compacting and CMIC present development platform
The new development platform is set to be unveiled for the first time at a joint event in June 2025. Both partners plan to systematically expand their cooperation in long term with the aim of establishing a comprehensive service portfolio.
