How To Choose An Immunoassay Platform For Cell & Gene Therapy Bioanalysis

The key factors to automating assay development to get results quicker Given the recent approval of an adeno-associated viral (AAV) vector gene therapy for spinal muscular atrophy (SMA) and the healthy pipeline of new treatments in development, the gene therapy landscape is highly competitive and timelines are compressed to bring new therapies to market. In addition, the focus on patient safety creates very specialized demands on bioanalytical methods utilized for vector and host cell protein quantitation, and for immunogenicity monitoring. Since immunoassays are traditionally time consuming and laborious, choosing the right immunoassay platform to meet the demands of data quality and assay speed significantly affects development timelines and deadlines for regulatory submissions. These are key factors to consider when choosing an immunoassay platform for cell and gene therapy bioanalysis in preclinical, clinical, and bioprocessing stages of development.