Recipharm, the contract development and manufacturing organization (CDMO), has announced an investment of over Euro 1.2 million ($1.3 million) to enhance its small scale Good Manufacturing Practice (GMP) active pharmaceutical ingredient (API) development and manufacturing capabilities in Paderno Dugnano, Italy.
The investment, which is in response to growing demand for Recipharm’s custom synthesis and early phase API manufacturing capabilities, has seen the opening of a new GMP kilo laboratory. The new area enhances the output of the facility’s existing laboratories and offers a fully GMP compliant service.
Commenting on the investment, Matteo Zacché, R&D manager at Recipharm in Paderno Dugnano, said: “This project is of strategic importance to Recipharm, enhancing our ability to offer drug developers a complete service offering from raw material to finished drug product”.
“With the addition of the new laboratory, we are now able to run up to six customer projects in parallel, handling maximum batch sizes of approximately 5 kg, compared to 1 kg previously. As well as increasing our output, we will also be investing in a number of new technologies, including flow chemistry, chromatography and hydrogenation capabilities in line with growing customer demand.”
As part of the investment, the facility’s existing chemical development laboratories have been upgraded, with the addition of new technologies and a dedicated unit for analytical development and method analysis activities. Analytical technologies under evaluation include high performance liquid chromatography-mass spectrometry (HPLC-MS), gas chromatography-mass spectrometry (GC-MS), nuclear magnetic resonance (NMR) spectroscopy and ultra-performance liquid chromatography (UPLC) method scouting solutions.
To support the new capabilities, Recipharm plans to double its R&D team in Paderno Dugnano over the next three years.
Recipharm’s team in Paderno Dugnano specialize in the GMP scale-up and manufacture of APIs for all clinical phases, from gram to kilo and pilot scale to commercial supply. The facility has advanced technical transfer capabilities and expertise in the development of chemical processes and analytical methods up to registration on a global basis.