In this article from Bioanalysis, the authors give their perspectives and findings in exploring a hybrid LBA/LC–MS as an orthogonal bioanalytical tool for clinical immunogenicity assessments.
In this interview, Jon Haulenbeek (Bristol-Myers Squibb; NJ, USA) discusses his role as a Group Leader running the Reagent Center of Excellence in the Translational Medicine Division.
In this interview, Hanna Ritzén (Mercodia; Uppsala, Sweden) provides an insight into 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
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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.