Eurofins provides custom synthesis and radiosynthesis capabilities
By James M. Schmidt, Senior Scientific Advisor, Custom Synthesis
Pharmaceutical companies often require the custom synthesis of test substances to support their research and development efforts. These include, but are not limited to reference standards, stable-labeled substances (esp. 2H, 13C, and 15N) for use as bio-analytical standards, or radiolabeled (esp. 14C or 3H) material for use in preclinical animal studies or clinical studies in patients, to establish adsorption, distribution, and excretion patterns and mass balance and to profile and identify excreted and circulating parent compound and metabolites.
Providing sponsors with accurate and timely proposals for radiolabeled synthesis and executing the programs to high quality standards requires experience and expertise on many aspects: advising customers on regulatory aspects (GMP vs. non-GMP), recommendations on synthesis routes and preferred position of the radiolabel on the molecule, biosynthetic approaches, advice on employing other (or multiple) isotopes, repurification and recharacterisation of existing materials, and much more.
From beginning to end, communication is key to a successful client-CRO relationship, and it’s especially important for custom synthesis as the test substance supply is a critical material for the studies it supports. It all begins in the proposal process where we discuss the client’s study design, material and timing needs, institutional knowledge on the chemistry, future supply needs, and more.Once a synthesis campaign is underway, the communication continues with frequent updates on progress.
Eurofins’ recently acquired Columbia, Missouri location (EAG Laboratories) has been providing custom synthesis support for almost two decades, with special expertise in synthesis of radiolabeled materials. In addition to a synthesis R&D laboratory, the site maintains four Class 10,000 synthesis suites and the rigorous cGMP-compliant environment required to produce certified radiolabeled products suitable for human clinical trials. This team of developmental synthetic chemists is technically exceptional and is backed by a dedicated analytical and quality control scientific staff.
Likewise, recent acquisitions have now brought additional excellent custom synthesis support to the Eurofins family at the EAG-St Louis (MO, USA) and Selcia (Ongar, UK) laboratories.
For more information, visit: www.eag.com/ services/synthesis/custom-synthesis-radiolabeling.