SEOUL, KOREA

Clinical trials of new drugs involve a series of rigorous tests in healthy normal volunteers before proceeding to efficacy trials in subjects manifesting the disease state for which the drug is being developed. A key component of these studies is to use a heavy carbon isotope labeled drug and measure the Absorption, Distribution, Metabolism and Elimination (ADME) of the drug within the human body. These 14C- ADME studies are the most definitive metabolic picture available in early clinical development, and build insight regarding the success or failure of the drug molecule.

Such ADME studies to date have been propelled by a sophisticated big physics atom counter, Accelerator Mass Spectrometry or AMS. The AMS was the only instrument capable of ensuring a successful set of data after administration of harmlessly small human doses (microdosing and microtracing). However, the multi-million-dollar instrument requires trained PhD level staff and can be the size of a small submarine.

A far simpler means of obtaining the same results has developed by a California Based Company, Picarro, in Cavity Ring Down Laser Spectroscopy (CRDS). Korea, and more specifically BioCore, had the unique opportunity to beta test the first (and as of yet only) Cavity Ring Down Spectrometer (CRDS) specifically designed to replace bulky AMS. The CRDS instrument does so in a robust, compact, easy to use design that can be installed in any laboratory.

For ~6 months Picarro loaned the instrument to BioCore to obtain feedback from real world testing. The promise of a paradigm shift in bioanalysis attracted the attention of a Global Pharmaceutical Company in Switzerland. As a result, this company commissioned a set of studies in animals (as surrogates for humans) using a 14C-labeled Biologic molecule drug candidate; the samples were sent to BioCore for analysis by CRDS and the current “gold standard”, AMS. The resulting dataset was impressive and validated the value and performance of the CRDS instrument. The CRDS delivered statistically the same data as the AMS, but in a far simpler and convenient format.    The data very quickly went to press in PLOS ONE, a mega journal that reaches all areas of science. The article, “Nanotracing and cavity-ring down spectroscopy: A new ultrasensitive approach in molecule drug disposition studies” can be found at the following link at PLOS ONE as a free download. https://journals.plos.org/plosone/article/authors?id=10.1371/journal.pone.0205435

Dr. Hwang Seung Yong, CEO of BioCore, added his thoughts on the collaboration. “Through this research, I am pleased to have the opportunity to collaborate with a new concept equipment and a global pharmaceutical company for the first time in the world. In the future, BioCore will continue to research and develop to be one of the best companion CROs in the era of precision medical care”. Indeed, advanced detection technology is the heart of BioCore, thus CRDS is a perfect tool to augment existing services and create new opportunities.

The CRDS instruments is a major leap forward – the laser cell that can fit inside a shoebox and requires no maintenance. The cost benefits will be substantial relative to AMS and the instrument will strengthen Seoul’s reputation as a leading clinical trial center. Moreover, hospitals and Universities that could not afford AMS will now have the same power at their fingertips as the large national labs. The definitive ADME study will be far easier to plan and implement. A product release date has not yet been set, but the instrument is far past the concept stage and ready for commercialization.

Contact Dr. Stephen Dueker at sdueker1@gmail.com to discuss CRDS opportunities or BioCore Bioanalytical Services