Development of identity assay for human papillomavirus genotypes using Simple Plex™ microfluidic automated ELISA

The IVRP (In-vitro Relative Potency) assay is a sandwich-type immunoassay used to measure relative potency as well as identity for some vaccine products. However, this traditional enzyme-linked immunosorbent assay (ELISA) method is time consuming due to the labor-intensive hands-on approach especially for multivalent vaccine products such as Human Papillomavirus (HPV). Development of a quick and simple assay for specific and faster identification of all nine genotypes of Gardasil®9 HPV vaccine was evaluated using ProteinSimple's Simple Plex Ella™ technology which can assist in sample transport vial identification and drug product formulation. An analysis of cross-reactivity for each antibody against each HPV genotype was conducted and showed high specificity of the new assay. The technology employed confers the assay's extremely fast analysis turn-around-time in a high throughput atmosphere, the Ella™ is also designed to run each well in triplicate which allows for more samples to be analyzed on an individual plate, while using less reagents than the typical ELISA based assay. The Ella™ also has scalable plates if less or more samples need to be tested, therefore having high potential to replace the manual ELISA identity assay. The instrument operational process is completely automated, including all antibodies, samples additions, as well as all wash steps, enabling result generation in approximately an hour. • Quick and simple Identification assay for Human Papillomavirus. • High-throughput automated ELISA assay for Drug Substance and Drug Product. • Sample saving and highly specific testing to support bulk or vial product identity.