Drugs tracked in Ongar: Selcia opens radiolabelled API plant
The facility in Ongar, Essex will make labelled active pharmaceutical ingredients (APIs) that are used in pharmacokinetic studies.
Spokesman Dave Roberts told us demand for specialist radiolabelling services has increased in recent years as a result of pharmaceutical industry cost cutting.
“In former times most drug were discovered by big pharma, who often had internal radiochemistry groups. Nowadays most new small molecules are now being invented by biotechs and small pharmaceutical companies which have no radiochemistry capability.
“At the same time big pharma are outsourcing more of their 14C GMP API production to companies like Selcia which have the prerequisite MHRA approved certification.”
He cited preclinical studies focused on the distribution and metabolism of drug compounds and environmental fate and dermal penetration studies as areas in which the firm is seeing strongest demand.
Safety concerns
Another driver for the development of the new product site is growing regulatory concerns about safety, particularly in first-in-man studies.
“Safety, quality and regulatory requirements, and the need to ensure patient safety, have increased demand that radiolabelled material be qualified as 14C GMP API. “
Selcia is one of three companies to offer 14C labelled API manufacturing services in the UK. It works with pharmaceutical companies, the majority of which are based overseas.
The firm also works with other contractors Roberts said, explaining that it has relationships with “most of the leading CROs which use 14C radiolabelled compounds.
He added that: “The [pharmaceutical industry] client then has freedom to choose the most appropriate CRO, based on its specific expertise, for their radiolabelled study.”
Capacity hike
Selcia currently employs a staff of 70 however, according to Roberts, the CRO plans to hire more.
“We are currently hiring new radiochemists and synthetic organic chemists who will work in the existing and new facility.”
