In this feature, we explore the key qualities to look for to ensure success when outsourcing immunogenicity assay development and testing. We also explore the methods for – and challenges involved with – T-cell immunity monitoring and assay development.
This infographic highlights the key qualities to look for in a CRO to ensure the best results when outsourcing immunogenicity assay development and testing.
In this interview Joel Mathews (Ionis Pharmaceuticals Inc., CA, USA) discusses his role in the development of biomarker, PK and immunogenicity assays in the development of protein therapeutics. He explains his interest in the field and explores the use of LBA for biomarker validation
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 editorial Sally Fischer (Genentech; CA, USA) explores ligand binding assay technologies: how to match the right tool to the bioanalytical challenge.
In this report from Bioanalysis, the authors summaries key points discussed the Bioanalysis Zone panel discussion filmed during the 12th Workshop on Recent Issues in Bioanalysis which focused on the topic of new technology integration into bioanalytical workflows.
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.
Arno Kromminga and Lydia Michaut will discuss the strategies and challenges of immunogenicity assessment for gene therapy compounds.
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 – LBA/cell-based assays: immunogenicity, biomarkers and PK assays)
This part of the 2018 White Paper published in Bioanalysis covers the recommendations for large molecule bioanalysis, biomarkers and immunogenicity using LBA and cell-based assays.
The speakers from our January panel discussion on immunogenicity answer further questions from the live event