14.11.2011. – GalChimia, a contract research organization (CRO) that provides custom synthesis and drug discovery services to the pharmaceutical and biotechnology industries and Applus+ LGAI, the testing and laboratory division of Applus+, have decided to combine their capabilities to offer a wider and complete set of services to the Pharmaceutical sector for chemical product development. This strategic alliance will position the new organization GalchimiApplus as one of the very few companies able to perform Research & Development (R&D), scale up and small production, as well as analytical developments and validation. In addition, the value proposition of GalChimiApplus will allow pharmaceutical and biotech companies to outsource part of their product & process development reducing time to maket, costs and production risks associated with R&D.
Jordi Brufau, managing director of Applus+ LGAI explains: “We are very keen about this new collaboration with GalChimia. It is really a step forward for the Fine Chemicals Department; and it follows the common strategy that we want to imprint in Applus+ LGAI, to help customers right from product conception”.
Carme Pampín, CEO of GalChimia, said: “We have a wide base of international clients, pharma and biotech companies, that trust us for their Drug Discovery efforts and small scale synthesis. The alliance with Applus+ will allow us to work with them along all the value chain, including GMP batches.”
Both companies will share their expertise acquired during years, with hundreds of processes developed, translating this synergy into a competitive asset. GalChimiApplus will count with state-of-the-art R&D labs and production plant as well as a strong Analytical Department.
The R&D section will study and optimize the synthetic steps of a route, using a broad range of common lab equipment, parallelization reactors, chromatography equipment, DoE software and other advanced tools. All the synthetic work will be backed up by all the analytical techniques available.
The multi-purpose pilot plant, distributed in four different levels with more than 3.6 m3 of reaction capacity and working in three shifts, will allow the production of products under GMPs, from hundreds of grams of a fine chemical, kilograms of an NCE intended for clinical trials or tons of an API.
The analytical services will use qualified laboratory tests under European and American pharmacopoeias for quality control of both raw materials and finished products, covering everything from microbiological control, physicochemical properties up to validation of analysis methods, using a wide arraw of techniques including GC-MS, LC-MS, UPLC, ICP, IR, UV and others.
GalChimiApplus will be especially careful to guarantee customer confidentiality at all times.