Pharmaceutical Business review

C2N, Cambridge Isotope Laboratories partner to commercialize Kinetic biomarkers

Under the partnership, C2N is eligible to access large quantities of highly enriched stable isotopes at predictable prices in support of its platform of Stable Isotope Labeling Kinetic (SILK)-based biomarkers.

SILK-based biomarkers, including such ones have the ability to detect early Alzheimer’s pathology much before the onset of clinical symptoms as well as to measure treatment responsiveness in preclinical and clinical drug studies.

Additionally, C2N will also receive an upfront payment and commercial milestone fees as well as huge quantities of GMP-grade stable isotope (13C6) labeled leucine (L-Leucine) for use in future upcoming clinical validation studies involving C2N’s SILK-based tests.

Further, CIL will invest in its own infrastructure and manufacturing processes to help meet the demand of stable isotopes in future for incorporation into C2N’s tests.

C2N CEO Dr Joel Braunstein stated that the logistics of having adequate supply of these reagents to enable disease screening on large numbers of at-risk individuals are far from trivial.

"As we expand the use of our SILK-based biomarkers beyond research services and into clinical diagnostic applications, CIL will be an instrumental partner to help us qualify our test kits and to produce L-Leucine under GMP scaled-up conditions," Braunstein added.