We had a great discussion led by Roche in the immunogenicity working group this morning. A new reagent is available that selectively cleaves IgM heavy chain, breaking apart the complex into 5 "Fab2" fragments and the 5-mer HC linked with the J chain. With the lower affinity of the IgM CDR, the loss of avidity reducing binding dramatically.
In addition to the immunogenicity applications, I thought the suggestion for further exploration within immunoassays in RA population. I completely agree that this reagent could be an interesting tool in our repertoire and wanted to bring to the attention beyond the immunogenicity group to those working in PK, biomarker, and diagnostic assays. Does anyone have experience testing this reagent in those formats?
In the spirit of not reading as a sales pitch (even though no conflict of interest), I instead direct you to the methods section of the Roche published manuscript on the AAV immune complex method (available open access): Novel assay format for total anti-adeno-associated virus antibody detection with low capsid consumption and built-in specificity control
------------------------------
Joleen White Ph.D.
AAPS 2024 Global Health Community Chair
Bioanalytical 101 Course Development
Senior Advisor
BioData Solutions LLC
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------