Selcia opens new dedicated 14C GMP API facility

Published: 25-May-2016

To help the firm meet increasing demand for 14C radiolabelled compounds

Selcia, a privately held company providing both carbon-14 (14C) radiolabelling and integrated drug discovery services, has opened a new state-of-the-art laboratory dedicated to the manufacture of 14C radiolabelled GMP active pharmaceutical ingredients at its facility in Ongar, Essex, UK.

The firm says its radiolabelling business is growing at 'an exceptional pace' and this expansion will help it meet increasing demand for 14C radiolabelled compounds. Such compounds are used to help understand the pharmacokinetic behaviour of parent drug and human specific metabolites in first-in-man studies.

Clive Cornell, Selcia's Chief Operating Officer, said: '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 to drug interactions, along with traditional mass balance studies, are driving demand and this increased capacity will help us meet challenging project timelines.

The investment in this new facility allows Selcia to perform multiple API projects simultaneously

'Our clients also benefit from Selcia’s established relationships with leading CROs and clinics. We have already successfully delivered more than 40 GMP API projects for our customers.'

Dr Gill Little, Selcia's Divisional Director – Radiochemistry and Analytics, added that quality continues to be at the heart of the firm’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,' she said.

'The new 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.'

You may also like