High-performance immunoassays in vaccine development and bioprocess
Vaccine development involves a large number of tests to support vaccine R&D, from early, pre-clinical studies to final production, testing, and release of batches. Bioanalysis during vaccine development presents many challenges in assay diversity and complexity, sample matrices, analyte types, and demands on workflow efficiency. Immunoassays are used to characterize vaccine titer, vector titer, purity, affinity, and potency, as well as immunogenic response in both animals and humans.
Samples for analysis vary greatly, with a wide range of analytes that include polysaccharides, proteins and peptides that must be measured in diverse matrices. Added to that, the new generation of vaccines involves increasing numbers of antigens.
Plate-based immunoassays have become the gold standard for many aspects of vaccine bioanalysis, including quantifying antigen epitopes, assessing impurity levels, and vaccine potency assays such as vaccine titer and immunogenicity. The search for improved immunoassay performance includes:
- The use of smaller amounts of precious reagents, such as vaccine candidate molecules, and samples from small test animals
- Assays that can readily handle serum and plasma samples, formulations with aluminum particles, and emulsions
- Reduction of hands-on time
- Reduction of assay development time
Examples of Gyrolab immunoassays in vaccine R&D and manufacturing
Gyrolab system can be used in a wide range of applications within vaccine R&D and manufacturing.
Rapid detection of antigen-specific antibodies in serum
Measuring the quantity and quality of antibodies in vaccinated subjects is key to understanding how protective lifelong antibody responses can be induced. To increase throughput, a team at Novartis Vaccines and Diagnostics transferred a laborious ELISA to Gyrolab system to enable rapid analysis of IgG subclasses to characterize memory B cell responses in mice vaccinated with Neisseria antigen together with three adjuvants.