The potential of antibody drug conjugates (ADCs) to provide targeted therapies for cancers and other devastating diseases have made them popular candidates for drug development programs. However, as we discussed recently in Drug Discovery and Development, the failure of several ADCs during phase II and III trials due to limited efficacy proves more complete bioanalysis is needed at the preclinical stage. Better preclinical analysis will better inform ADC development programs about efficacy and safety issues, while saving costs down the line.
Outsourcing Antibody Drug Conjugate Analysis
In our “How to Select the Right CRO for ADC Development” post, we highlighted that ADC complexity stems from the many analytes to examine, which consist of both large and small molecules. Proper characterization of an ADC therefore requires expertise in ligand binding assays (LBAs) and liquid chromatography-mass spectrometry (LC-MS), and a program that emphasizes collaboration between the respective groups.
As biopharma companies continue to specialize in core competencies, many analytical scientists are moving to the bioanalytical CRO space, fueling growth and innovation among bioanalytical specialty firms. Thus pharma is increasingly outsourcing this area of ADC development. In addition, a bioanalytical CRO is routinely exposed to a variety of FDA-regulated studies, therefore bioanalytical laboratory services often maintain quality systems that exceed regulatory standards and are well versed in the latest industry trends in assay development.