The good manufacturing practice (GMP) quality plant, located next to PerkinElmer’s existing facility in Boston, Massachusetts, will carry out custom radiosynthesis and labelling of drug compounds for pharma and biotech clients.
Pat Mayer, PerkinElmer’s product leader for research reagents and bio-discovery, explained that global demand for this type of service has increased considerably in recent years.
Mayer told Outsourcing-pharma that: “the FDA's suggestion that cGMP qualified radiosynthesized products are used for [Absorption, Distribution, Metabolism and Excretion] ADME testing,” was a key motivation for setting up the new facility.
She added that operations are tailored to the client’s specific need as well as the choice of labelling isotope.
Mayer explained that: “In general compounds labeled with Carbon-14 are complex syntheses while those compounds to be labeled with tritium start with compounds supplied by customers.”
PerkinElmer’s Boston facility, which is fully operational and has staff of 150 people, also provides packaging services which, as Mayer explained, can be a critical factor in determining how successfully radiolabelled compounds are used.
Mayer explained that: “Packaging is performed in the suite in a clean environment. special consideration is given to the packaging container based on the client’s use of the product at their CRO.”
She went on to say that: “We have many years of experience packaging and shipping radiochemicals and understand the special package labeling required [for the shipment of] radioactive products.”
Mayer also stressed the importance of efficient delivery, explaining that: “Timely shipments are important to preserving the utility of [radiolabelled] product.”
Growing demand for radiolabelling
While ADME analysis of radiolabelled compounds is not a new idea, the need to improve R&D efficiency and make earlier development decisions for drug candidates means that demand for this type of service is set to increase.
Further evidence of this demand is provided by recent moves by contract research organizations (CROs) like Covance and Quotient Bioresearch to expand their offerings in ADME testing.