Recipharm Invests in its Italian API Facility
News Nov 10, 2016
Recipharm has announced an investment of over €1.2 million to enhance its small scale 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 specialise 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.
Source: Story from Recipharm. Please note: The content above may have been edited to ensure it is in keeping with Technology Networks' style and length guidelines.
Lonza Expands Encapsulation and HPAPI Capabilities in North AmericaNews
Expanding our capabilities into commercial-scale encapsulation responds to our customers' desire to maintain programs at the Tampa, FL (USA) site from clinical development to commercialization.READ MORE
Researchers Discover Key Link Between Mitochondria and Cocaine AddictionNews
Researchers were able to block response in mitochondria to cocaine.READ MORE
A Greener Way to Make KetonesNews
Researchers at McGill University have discovered a new, more environmentally friendly way to make ketones, an important chemical ingredient in pharmaceuticals. While ketones are found in a wide range of useful chemicals, they are commonly prepared through energy-intensive, multi-step technologies that create significant chemical waste.READ MORE
Comments | 0 ADD COMMENT
World Advanced Therapies & Regenerative Medicine Congress
May 16 - May 18, 2018