White Paper: Choosing an Immunoassay Platform for Cell and Gene Therapy Bioanalysis

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 competitive and timelines are compressed for bringing 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 affect development timelines and deadlines for regulatory submissions.

This White Paper describes key factors to consider when choosing an immunoassay platform for cell and gene therapy bioanalysis in preclinical, clinical, and bioprocessing stages of development.