Ligand binding assays (LBA) are analytical procedures to quantify an analyte (macromolecule) based on its affinity for a ligand, including but not limited to antibodies, antigens, receptors, oligonucleotides and peptides. Typical LBA platforms include traditional enzyme-linked immunosorbent assay (ELISA), Meso Scale Discovery (MSD), Gyros, and Radioimmunoassay (RIA). Ligand binding assays performed by biopharmaceutical CROs are specially designed to support analyses such as in vitro screening, pharmacokinetics (PK), immunogenicity and biomarker studies. They used throughout all stages of the drug discovery process from candidate drug screening to post-marketing monitoring.
Alliance Pharma’s Biopharmaceutical Department can support outsourced projects to modify and validate existing methods, or to develop a novel method for bioanalysis using traditional ELISA, MSD, Gyros, or RIA platforms. Through our vigorous validation process, a method will be established as reliable and reproducible for the quantification of a given analyte or analytes. A common validation package includes standard curve evaluation, precision and accuracy assessment, selectivity and matrix effect, dilution linearity and prozone effect, and relative analyte/matrix stability analyses. Additional experiments such as co-administered drug interference, effect from lipemic or hemolysed plasma, or whole blood on quantification of the analyte may also be assessed. As a result, subsequent sample analyses are conducted with a well-established method, ensuring the highest data quality and integrity.