Preclinical Studies

For preclinical research teams needing to accurately measure therapeutic protein levels or high potency drugs in preclinical species, Xceleron’s preclinical AMS studies can offer practical advantages over other analytical techniques.

Preclinical Evaluation of Biologics

For accurate, quantitative data on PK and distribution of biological drug candidates, including proteins, antibodies, polynucleotides and polycarbohydrates, Xceleron provides a ¹⁴C protein labeling/AMS method as an attractive alternative to ELISA assays.

Preclinical research teams spend significant effort on developing ELISA assays, many of which become redundant as the therapeutic proteins proceed through the development cycle. Our preclinical AMS studies deliver generic quantitative assays irrespective of species or tissue type and independent of compound structure.

Preclinical Studies of High Potency Drugs

Because of the ultra-sensitive nature of AMS analysis, we can quantify drug levels in various body fluids and tissues even when they have been administered at very low dose levels. For high potency drugs, this means that we have the required sensitivity to enable preclinical research teams to administer ultra-low levels of their high potency drug and still obtain an accurate result.

In one example, the estimated limit of quantification (LOQ) of our technique has been found to be 15 times lower than the corresponding ELISA LOQ.

Xceleron’s experience in this area includes: animal distribution studies with vaccine adjuvants, screening PK studies with IgG in rat and biologically-active polysaccharide distribution studies.