Pre-Clinical Evaluation
Our clients ask us to conduct preclinical AMS studies for two general purposes:
Biologics - Pre-clinical evaluation of developmental drug candidates, including proteins, antibodies, polynucleotides and polycarbohydrates
High potency drugs - AMS delivers the required sensitivity to be able to measure very low levels
Xceleron has developed methods for 14C labeling for proteins and other high molecular weight materials. One application for this has been an alternative for ELISA assays in early development. ELISA remains the most common method of therapeutic protein measurement but significant effort is required in the development of the assay. Many of these ELISA assays may become redundant as the therapeutic proteins proceeds through the development cycle. 14C labeling the protein, and then using AMS, enables generic quantitative assays to be established irrespective of species or tissue type.
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.
Please see the paper below that was published with Cambridge Antibody Technologies on the quantification of low levels of systemic therapeutic recombinant protein in rat.
