In this interview, Hanna Ritzén (Mercodia; Uppsala, Sweden) provides an insight in her recent article on classification of commercial LBA kits for biomarkers, and why this area of bioanalysis is important.
In this interview, Wenying Jian (Janssen Research & Development, Johnson & Johnson; NY, USA) describes the basic principles of hybrid LBA/LC–MS and how this technique can be used to quantify proteins.
Product: Gyrolab® xPand – the automated, high- throughput immunoassay system that maximizes productivity in biotherapeutic discovery, development and production
Gyros Protein Technologies AB, a pioneer in automated nanoliter-scale immunoassay platforms and leading provider of peptide synthesizers and reagents has developed Gyrolab® xPand to provide high-throughput, flexibility and rapid analysis of large sample numbers for a range of biotherapeutic applications. The proprietary Gyrolab CD technology, with highly reproducible nanoliter microfluidics, is integrated with Gyrolab platforms to automate nanoliter-scale immunoassays with parallel processing, using laser-induced fluorescence detection.
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis
In this White Paper from Bioanalysis the authors highlight the need the bioanalytical community has for commercial kits able to be used for regulated drug development.
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies’ inputs on bioanalysis, biomarkers and immunogenicity)
This part of the 2018 White Paper published in Bioanalysis focuses on the recommendations for PK, PD and ADA assays by hybrid LBA/LCMS and regulatory agencies’ input.
In this Bioanalysis Zone interview, Pegah Jalili (MilliporeSigma) discusses her current work in analytical R&D of biotherapeutic characterization and quantification, and what she thinks the future looks like for this field of bioanalysis.
In this Editorial from Bioanalysis, the authors consider the future for hybrid assays following the US FDA recently issued guidance for hybrid assays. Find out more and access the full article, exclusively for Bioanalysis Zone members.
Find out more about the evolution of fit-for-purpose biomarker validations from an LBA perspective in this free article from Bioanalysis.
Parallelism experiments to evaluate matrix effects, selectivity and sensitivity in ligand-binding assay method development: pros and cons
This review compares and discusses all available approaches that can be used to assess key assay parameters for pharmacokinetic and biomarker ligand-binding assays. Find out more in this article from Bioanalysis.
3-(4-Hydroxyphenyl)propionic acid: the forgotten detection substrate for ligand-binding assay-based bioanalysis
In this review article the authors outline the increase in sensitivity and dynamic range when using fluorogenic 3-(4-hydroxyphenyl)propionic acid in preference of other conventional colorimetric ELISA, LBA technologies and LC-MS assays.