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news.Almac Group, an integrated contract development and manufacturing organization which supports the international pharmaceutical and biotechnology industries, has bolstered its radiolabeling capabilities by expanding facilities with the addition of new laboratories, reported PMPNews.com.
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Reportedly, in May 2009, Almac Group was officially accredited for cGMP manufacturing and received investigational medicinal products (IMP) drug product-manufacturing license from the Medicines and Healthcare Regulatory Agency (MHRA).
The expanded laboratories will consist of nearly 20 new workstations, 14 synthesis and a further 6 general workstations for chemistry and analysis.
The expanded facilities will also contain a new manufacturing finishing suite for the development of IMPs used in clinical trials and the final steps in active pharmaceutical ingredients (API) manufacturing, which allows analytical chemists to carry out critical testing of a labeled IMP and undergo x-ray powered diffraction (XRPD) to determine the degree of polymorphism in the very facility.
Dr Rick Dyer, vice president of operations at Almac, said: ““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.”