Eurofins BPT Columbia Expands cGMP Radiolabeling Labs

by Harley Wilcox, Senior Scientific Advisor

Radiolabeling Lab Radio labeling of drugs continues to be essential in support of ADME studies for pharmaceuticals in development. Radiolabels allow for efficient monitoring of absorption and metabolic profiles via specific mass or radioactive detection. Eurofins BioPharma Product Testing Columbia’s cGMP synthesis facility have been providing labeling and other synthesis offering for over 20 years. Based in Missouri, the current synthesis staff has on average more than 10 years of experience.

Due to continued and higher request for radio synthesis, a recent expansion of these specialized laboratories has been completed. Three new laboratory hoods and laboratory updates will allow for higher capacity and more efficient services. The laboratory offers four cGMP suites. The facilities primary service offering centers on stable and radio-labeled compounds to support GLP, cGMP and non-regulated projects. Other small scale synthesis projects may be considered. Carbon 14 continues to be a primary request along with stable labels incorporating deuterium, ¹³C and ¹⁵N.

Analytical support in addition to GLP and cGMP CoA release testing includes:

Full stability support
NMR
Chiral analysis
Assay and impurity analysis
Residual solvents
Radio purity
Release testing
Protocol driven phase appropriate method transfers and validations

Eurofins BPT looks forward to supporting your isotopic labeling needs and is pleased to offer technical consultation to aide in synthesis routes and position labeling.

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