Webinar available to view on demand. Methods for the detection of drug-induced antibodies have become much more sensitive, but the question remains to be answered: are antibodies at this low concentration level clinically relevant?
Blood samples from patients affected by an autoimmune disease demonstrate a significant increase in a specific type of immune cells, called T follicular regulatory cells.
All biological protein drugs are immunogenic, which may lead to severe clinical consequences. This makes knowledge of the scientific and regulatory aspects of immunogenicity a must for every drug manufacturer.
LC–MS quantification of protein drugs: validating protein LC–MS methods with predigestion immunocapture
The purpose of this paper is to describe validation experiments that measure immunocapture efficiency, digestion efficiency, matrix effect and selectivity/specificity that can be used during method optimization and validation to test the resistance of the method to these potential interferences. The designs and benefits of these experiments are discussed in this report using an actual assay case study.
Researchers from Linköping University may have identified diagnostic biomarkers for multiple sclerosis, which could assist clinicians in distinguishing the severity of the disease.
Best practice recommendations for the transfer of cell-based assays for the measurement of neutralizing anti-drug antibodies
The authors present lessons learned from two cell-based assay transfers that met relevant challenges while implementing alternative permutations of the recommended method transfer process.
Significant differences in immune parameters seen in manic bipolar patients reveal potential biomarkers
Immune system dysregulation has previously been linked with pathophysiologic changes of the central nervous system.…
New analytical application of antibody-based biosensor in estimation of thyroid-stimulating hormone in serum
In this study, an immunosensor-based, kinetic-exclusion analysis (KinExA) was used for thyroid-stimulating hormone estimation.
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity)
This White Paper (part 3 of 3) from the 2015 9th Workshop on Recent Issues in Bioanalysis (WRIB) covers large molecule bioanalysis using LBA, biomarkers and immunogenicity.