Selcia Opens New Dedicated 14C GMP API Facility
Ongar, UK, 25th May 2016 / Sciad Newswire / Selcia today opened its new state-of-the-art laboratory dedicated to the manufacture of 14C radiolabelled GMP API (Drug Substance). Selcia’s radiolabelling business is growing at an exceptional pace and this expansion will help meet the increasing demand for 14C radiolabelled compounds. Such radiolabelled compounds are used to help understand the pharmacokinetic behaviour of parent drug and human specific metabolites in first-in-man studies.
Clive Cornell, Chief Operating Officer, commented “The investment in this new facility allows Selcia to perform multiple API projects simultaneously. New study types using 14C compounds such as absolute bioavailability, 14C intravenous microtracer and drug-drug interactions along with traditional mass balance studies, are driving demand and this increased capacity will help us meet challenging project timelines. Our clients also benefit from Selcia’s established relationships with leading CROs and clinics. We have already successfully delivered over 40 GMP API projects for our customers.”
Dr. Gill Little, Divisional Director – Radiochemistry and Analytics, said “Quality continues to be at the heart of Selcia’s radiochemistry business. This new 14C GMP API laboratory meets the exacting standards required by our clients and the phase 1 units administering radiolabelled compounds to humans and helps to assure patient safety. The new GMP API facility releases capacity in our existing radiochemistry laboratories to allow for further expansion of our business. Additional radiochemists have been recruited to satisfy this customer demand.”
Selcia is a privately held company providing both carbon-14 (14C) radiolabelling and integrated drug discovery services, operating from a modern facility in Ongar, Essex, UK.
Selcia has a Good Manufacturing Practice (GMP) certificate from the MHRA for the preparation and 14C labelling of Active Pharmaceutical Ingredients (APIs). It produces 14C radiolabelled compounds for a global customer base encompassing both the life sciences and chemical industries. Applications of the radiolabelled products prepared by Selcia include: preclinical and clinical drug metabolism studies; mass balance, microtracer, dermal penetration and environmental fate studies.
Selcia’s analytical laboratory is a member of the MHRA UK GLP Compliance Monitoring Programme.
Tel: +44 7967 153753
For further details about Selcia’s Radiolabelling service please contact
Tel: +44 (0) 1277 367000
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