Almac Expands Radiolabeling Facilities to Include 14C API and IMP Supply
February 26, 2010
Launch of new MHRA audited facility will enable Almac to meet the rapid timelines required by Pharma companies in drug development.
Almac, an integrated contract development and manufacturing organization supporting the international pharmaceutical and biotechnology industries, has further enhanced its radiolabeling capabilities with a significant facility expansion.
The opening of the facility follows Almac’s official accreditation for cGMP manufacturing and the securing an Investigational Medicinal Products (IMP) drug product-manufacturing license, from the Medicines and Healthcare Regulatory Agency (MHRA) in May 2009.
The new laboratories are the culmination of nearly 5-years work by the Almac Group, since originally receiving a Carbon-14 license in 2005, and will be opened by Dr Ken Lawrie of GlaxoSmithKline, and Chairman of the International Isotopes Society (UK Group), on 26 February 2010.
The expanded laboratories will include some 20 new workstations, 14 synthesis and a further 6 ‘general’ workstations for chemistry and analysis. These facilities will be staffed by a 20 strong team of dedicated radiochemists, including Dr Sean Kitson who received the 2006 Wiley Journal of Labeled Compounds and Radiopharmaceuticals Young Scientists award for his work on the elaborate radiosynthesis of the Parkinson’s drug (R)-(-)-[6a-14C]apomorphine.
In addition, the expanded facilities will also feature a new, dedicated manufacturing finishing suite for the development of IMPs used in clinical trials, and the final steps in Active Pharmaceutical Ingredients (API) manufacture. This will allow analytical chemists to carry out critical testing of a labeled IMP and undergo x-ray powder diffraction (XRPD) to determine the degree of polymorphism, all on the same site.
Commenting on the announcement, Almac’s VP, Operations Dr Rick Dyer, said: “Almac has started the New Year with a firm resolution to provide a clear pathway for pharma companies to meet the radiolabeling requirements in Phase 1 to Phase 3 clinical trials, signaling our intent to work very closely with the high quality servicing needs of the sector. Our capability to provide cGMP for final drug candidates, peptides, small molecules and advanced intermediates responds competitively to the demands of the market. Almac also now offers QP release.”
For further information contact: Tristan Jervis Account Director De Facto Communications 330 High Holborn London WC1V 7QD T: +44 (0)207 861 3838 E: [email protected]
About Almac Group: Almac is a financially stable, privately owned organization with over 30 years experience. It provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation and analytical development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture and packaging.
The company has over 2,600 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters in PA started in July 2008 and will be completed in 2010.