Therapeutic Product Immunogenicity Community

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  • 1.  ADA assay to detect IgE when there is no true positive Ctrl

    Posted 03-09-2023 09:00

    Hi,

    Can anyone suggest a method to detect IgE? Currently, our method only detects the IgG.

    Thank you.

    Asma



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    Asma Ejaz, Ph.D.
    Principal Scientist II | Immunoanalytical Services | Charles River
    [email protected]
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  • 2.  RE: ADA assay to detect IgE when there is no true positive Ctrl

    Community Leadership
    Posted 03-10-2023 08:15

    ImmunoCAP™ may be the laboratory standard methodology-platform for detecting specific IgE to protein therapeutics, especially in the presence of high levels of specific IgG because of the platform sensitivity.  This was the methodology used in perhaps the best example of detection of IgE to a protein therapeutic ( Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose, N Engl J Med 2008; 358:1109-1117 DOI: 10.1056/NEJMoa074943).  A typical method for generating an IgE positive control is using standard molecular biology techniques to replace the Constant region DNA sequence from an IgG positive control and with IgE constant region DNA sequence and expressing the IgE protein. 



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    Robert Dodge Ph.D.
    Lead Biologics Products Bioanalysis
    Novartis
    Princeton NJ
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 3.  RE: ADA assay to detect IgE when there is no true positive Ctrl

    Posted 03-10-2023 11:23

    Thank you!



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    Asma Ejaz, Ph.D.
    Principal Scientist II | Immunoanalytical Services | Charles River
    [email protected]
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