ELISA

ELISA designates Enzyme-Linked Immunosorbent Assay, a widely used analytical technique that detects and quantifies proteins, antibodies, antigens, or other biomolecules through specific antibody binding coupled with enzyme-mediated signal generation. This assay format can be configured as direct, indirect, sandwich, or competitive designs depending on target type and required sensitivity, enabling reliable measurement across a broad concentration range in complex biological matrices.

The biopharmaceutical industry employs ELISA throughout discovery, development, and manufacturing to measure cytokines, therapeutic proteins, anti-drug antibodies, and residual impurities such as host cell proteins. Assay development requires optimising antibody pairs, blocking conditions, sample dilution strategies, and detection systems. Validation demonstrates performance characteristics including accuracy, precision, selectivity, and robustness under regulated requirements. ELISA data supports pharmacokinetic studies, potency assessments, stability programmes, and clinical trial biomarker monitoring. As assay automation and multiplex platforms advance, ELISA continues serving as a reliable, scalable tool supporting decision-making across the product lifecycle.