How to detect vector immunogenicity 24× faster and with 10× less sample
Cell and gene therapy promises to revolutionize medicine by correcting underlying genetic causes of disease or conferring new functions to cells to combat disease and has already seen spectacular successes in health care, ranging from curing rare eye diseases, to the treatment of sickle cell disease and a number of cancers. Immunoassays can be important analytical tools in cell and gene therapy and the careful choice of an immunoassay platform can improve productivity by boosting workflows, data quality and greatly reducing the consumption of precious samples, for example in detecting antibodies against lentivirus vectors that are commonly used in cell and gene therapy.
Determining the immunogenic potential of a therapeutic antibody is a regulatory requirement during clinical development since anti-drug antibodies (ADA) can cause undesirable effects, ranging from loss of drug exposure and efficacy to serious adverse events. Justine Brose and her colleagues at Novimmune SA, Geneva, Switzerland evaluated four platforms to determine which platform and sample pre-treatment procedures could deliver a fit-for-purpose assay for ADA analysis to determine the immunogenicity of the therapeutic antibody Novimab. Of the platforms tested (ELISA and Gyrolab, Meso Scale Discovery, and AlphaLISA platforms) only Gyrolab and MSD platforms met all of their pre-specified assay requirements.
Immunoassays are only as good as the reagents they build on. Following up on the post 
Anti-Drug Antibodies (ADA) can decrease drug half-life, reduce drug efficacy and even cause serious adverse reactions. Measuring ADA is therefore a key safety concern, but the immunoassays used to do this are complicated by the presence of drug and target in samples, which may severely reduce assay selectivity. This demands immunogenicity assays that are a balancing act between sufficient sensitivity, drug tolerance, and resistance to target interference.
