Immunoassays provide a fast, simple, and cost-effective method of detection with high sensitivity and specificity. They exploit the properties of antibodies to identify disease biomarkers, drugs, and other analytes. Without a secure stream of validated mAbs, IVD developers and manufacturers risk nonspecific binding, batch variability, or loss of supply – leading to wasted time and resources or project abandonment.
Sequencing the protein of the antibody reagent in parallel to assessing its affinity and specificity facilitates the development of reliable kits and immunoreagents securing research and manufacturing reproducibility. Obtaining protein sequences also enable recombinant expression, yielding consistent batches with predictable biological activity. Next generation protein sequencing (NGPS) can also help avoid issues with mAbs stemming from cell line drift, gene loss, and gene mutations.