Almac expands radiolabelling facilities to include 14C API and IMP supply.
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 radiolabelling 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 Labelled 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 labelled IMP and undergo x-ray powered 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 radiolabelling requirements in Phase 1 to Phase 3 clinical trials, signalling 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.”