Robust Method Development for Biologics and Biosimilars: Ligand binding assays are critical elements in the development and monitoring of biological medicines. Their robustness, accuracy, and reproducibility depends on the quality of bioanalytical reagents

摘要

Biological medicines have transformed patient care across a number of serious and debilitating disease areas, including cancers, inflammatory diseases, and immunological conditions. These complex and costly medicines represent a highly competitive and rapidly evolving area of the pharmaceutical industry. In particular, therapeutic antibodies such as Humira~? (adalimumab) are now among the top-selling drugs across the globe. Robust analytical data are critical in ensuring the development of efficacious medicines that meet stringent regulatory standards for patient safety. Bioanalytical platforms, tools, and reagents that offer exceptional levels of specificity are essential in ensuring the timely delivery of next-generation biologics.