Therapeutic Product Immunogenicity Community

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  • 1.  Pooling of ADA titer data from different labs

    This message was posted by a user wishing to remain anonymous
    Posted 05-21-2025 10:52
    This message was posted by a user wishing to remain anonymous

    Keen to understand the best practice when pooling ADA titer data from different labs with different MRD. Specifically, has the ratio of MRD been utilized for normalizing data from different labs?



  • 2.  RE: Pooling of ADA titer data from different labs

    Posted 05-22-2025 09:01

    Hi! I don't personally have experience with this challenge, but Fred McCush (Pfizer) gave a nice presentation at WRIB this year about ADA assays that moved around labs. So my guess is that he has experience about how the data was best handled from different labs. Hope that helps you!

    Cheers,

    Susan



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    Susan Irvin, PhD, PMP
    Regeneron Pharmaceuticals, Inc.
    Tarrytown, NY
    [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: Pooling of ADA titer data from different labs

    Posted 05-22-2025 13:28
    There is insufficient information here:  different labs/same method except MRD?  Was the assay validated at lab 1 then transferred to lab 2?  Or was the method developed/validated independently at the two labs?  Are the labs supporting the same protocol or different?  Same indication or different?  What would be the purpose of combining titers-some sort of  analysis of titer level impact?
    The above information would help with any response.  Absent that I would venture that with two different MRDs that the assays have different methods, though I'm guessing quite similar.  With different MRDs the cut points will be different and thus even the relative quantitation from a titration could be different, making combining titers problematic.  You could do a comparability experiment:  exchange samples from both labs and see what you get.  If the original titers are recovered then it would suggest combining might be ok.
    Depending on whether you have sufficient "n" in both labs, you could simply run independent analyses and see if the pattern is similar between labs.  The general observation is higher titers have greater impact, but the actual level of titer is usually not a good predictor of impact, I.e., same titer from different subject may have quite different impact.






  • 4.  RE: Pooling of ADA titer data from different labs

    Community Leadership
    Posted 05-22-2025 14:37

    There is an open access manuscript talking through some case studies of multiple immunogenicity assays within a program that you may find valuable. Fair disclosure: I am a co-author.

    https://www.tandfonline.com/doi/full/10.4155/bio-2019-0300



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    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.
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