Fast immunoassay validation with high-quality data
With R&D returns for large cap biopharma companies falling to the lowest level in nine years (Deloitte, 1), the escalating cost of bringing medicines to market means that the biopharma R&D process must be examined in detail. One important factor is the development and validation of immunoassays that can deliver high quality data efficiently and in a timely manner. Speed and quality are intertwined, and while manual ELISA has been a major workhorse in biopharma R&D, automation is a key factor in speeding up the generation of high quality data with minimum hands-on time, minimum need for re-runs, and using readily validated assays that meet regulatory requirements.
Harnessing the power of cell and gene therapy involves a large range of analytical methods that can deliver robust results to support rapid data driven decision-making. One assay development team has used immunoassays to track a transgene IgG product. Their choice of immunoassay platform enabled them to generate high quality data that supported Design of Experiments to quickly optimize cell culture.
In a previous post, 
The drive to achieve regulatory approval of protein-based drugs quickly and efficiently demands methods that can deliver reliable data to support studies in pharmacokinetics, toxicokinetics, pharmacodynamics, biomarker analysis, and immunogenicity. This need has powered the development of a wide and somewhat perplexing range of ligand binding assays (LBAs) and technology platforms designed to function in a regulated environment, from non-clinical studies to post approval. Added to that, developing an assay that is ready for validation can be a real challenge. If you need guidance in this area then you would do well to read ‘Ligand Binding Assays in the Regulated Bioanalytical Laboratory’, a book chapter authored by Johanna Mora
A number of serious eye diseases, such as neovascular age-related macular degeneration (AMD) and diabetic macular edema, involve increase in the leakage of blood vessels in the eye. This is caused by vascular endothelial growth factor (VEGF) and while such diseases can be treated with protein drugs that neutralize VEGF, the drugs must be administered frequently. A research group has developed an elegant approach that significantly extends the half-life of the drugs. This exciting work involved handling a challenge that is common to much of eye research – running immunoassays on precious samples in difficult matrices.
Bioanalytical laboratories often need to quickly develop robust immunoassays to support studies with tight timelines. Immunoassay performance is governed by many factors, such as reagent concentrations and sample dilution, and the classic experimental approach to improving assay performance involves changing one factor at a time. This approach is time consuming, misses important interactions between factors, and seldom leads to an optimal assay. There is an alternative, very powerful approach that has been used in many industries and applications to optimize processes – Design of Experiments (DOE). DOE has been successfully applied to immunoassay development by a number of research groups, including those using Gyrolab technology.
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.
