Recipharm Adds New Lab to Italian API Facility

Recipharm announced that it is investing more than EUR1.2 million to enhance its small-scale GMP API development and manufacturing capabilities in Paderno Dugnano, Italy. The investment was made to meet the growing demand for the CDMO’s custom synthesis and early phase API manufacturing capabilities. A new GMP kilo laboratory has been opened as a result. The new area enhances the output of the facility’s existing laboratories and offers a fully GMP compliant service.

Matteo Zacché, R&D Manager at Recipharm in Paderno Dugnano, commented in a press statement that with the addition of the new laboratory, Recipharm is now able to run up to six customer projects in parallel and handle maximum batch sizes of approximately 5 kg, compared to 1 kg previously. He added that Recipharm will also be investing in a number of new technologies such as flow chemistry, chromatography, and hydrogenation capabilities.

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.

Recipharm’s team in Paderno Dugnano specializes 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. The CDMO plans to double its team in Paderno Dugnano over the next three years to support the new capabilities.

Source: Recipharm