Selcia has opened its new state-of-the-art laboratory dedicated to the manufacture of 14C radiolabelled GMP API drug substance. The company says its radiolabelling business is growing at a fast pace and this expansion will help meet the increasing demand for 14C radiolabelled compounds. Such radiolabelled compounds are used to help understand the pharmacokinetic behavior of parent drug and human specific metabolites in first-in-man studies.

“The investment in this new facility allows Selcia to perform multiple API projects simultaneously,” said Clive Cornell, chief operating officer, Selcia. “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.”

“Quality continues to be at the heart of Selcia’s radiochemistry business,” said Gill Little, divisional director, radiochemistry and analytics, Selcia. “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.”