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Radiolabeling for ADME
WALTHAM, Mass.—In a move that both gives a nod to recommendations by the FDA and underscores the pharma and biotech industry's continuing desire to outsource specialized services, PerkinElmer announced last month the launch of its GMP Radiosynthesis Services to provide customized manufacturing of radiolabeled compounds for use in clinical studies.
According to Pat Mayer, product portfolio leader—research reagents for PerkinElmer, the launch of GMP-compliant services follows years of the company providing radiosynthesis of compounds for use in animal studies. The GMP-compliant services are targeted to companies conducting limited in-human ADME studies during late Phase II or Phase III clinical studies.
"We still have a big business in providing [lower grade] radiolabeled compounds for animal studies and it is a good piece of business," Mayer notes. "The launch of the GMP services comes as the FDA is strongly recommending—not requiring, yet—that synthesis of readiolabeled compounds for use in humans be GMP compliant."
By making the move to GMP-compliant manufacturing PerkinElmer is a bit ahead of the curve and is also prepared to serve the market should the FDA require GMP compliance for such materials in the future.
The growth curve is strong for these services and should get stronger in the future, says Darryl Cleary, vice president of manufacturing for Pharmasset Pharma Inc., who has used PerkinElmer's radiolabeling services in the past.
"Ten years ago, a number of pharmaceutical companies would do this work in house," notes Cleary. "They would have their own SOPs, their own storage for the radioactive material and their own employees trained in this. But as pharma companies continue to look to drive costs out of their systems, they don't want to have the dedicated staff and facility to do this."
There does need to be some trust involved in this kind of relationship, however. In order for PerkinElmer to provide its service, customers need to provide their compound to the company in order for PerkinElmer to perform the synthesis needed to radiolabel the compound.
The synthesis is neither easy nor cheap. Depending on the compound, the process could take as few as a handful of steps to upwards of a dozen or more, with turnaround times ranging anywhere from four to 10 weeks.
"I would estimate the cost to be anywhere from $75,000 to $175,000 for a company to get enough of their compound to put it into the six to eight people needed for the studies," Cleary says.
These studies are typically performed relatively late in the clinical trials process and are for the purposes of finding out exactly how particular compounds are metabolized by humans. Essentially, the study subjects will take the compound and clinicians will then collect all excretions from the subjects to measure how and where in the body the drug is being metabolized.
Mayer says its facility only works on one compound at a time and it was already booked for the GMP services through June 2009. And while it took a full year of planning, build-out and documentation to get its first facility up and running, it should take a lot less time for its second, which the company plans to open next year. DDN