Therapeutic Product Immunogenicity Community

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  • 1.  Current Practices in Preclinical ADA Testing

    Community Leadership
    Posted 28 days ago

    Hi all,

    We've recently had several discussions within the community around streamlined approaches to preclinical ADA testing in GLP toxicology studies. In parallel, we've seen evolving thinking in this space, including the strategic approach proposed by the EBF (Laurén et al., 2021. A strategic approach to nonclinical immunogenicity assessment: a recommendation from the European Bioanalysis Forum, link here).

    To better understand where the field currently stands, I've put together a short (~2 minute) poll to capture current industry practice.

    The survey explores:

    • Tiered vs streamlined ADA workflows (1-tier, 2-tier, 3-tier)
    • Trigger-based vs routine testing approaches
    • Key drivers influencing strategy selection

    If you're willing to contribute, the survey can be accessed here: Current Practices in Preclinical ADA Testing – Fill in form

    Responses will be treated confidentially, and only aggregated trends will be shared back with the community.

    I'd be very interested in capturing a broad range of sponsor and CRO perspectives.

    Thanks in advance for your input,

    Rob



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    Robert Nelson
    Scientific Officer, Executive Director
    BioAgilytix Laboratories
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer or other entities to which I am affiliated.
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  • 2.  RE: Current Practices in Preclinical ADA Testing

    Community Leadership
    Posted 19 days ago

    Thanks to those who have already contributed to this survey on current practices in preclinical ADA testing 

    If you would still like to be included, the poll is still open at this link:  Current Practices in Preclinical ADA Testing – Fill in form

    Best wishes,

    Rob



    ------------------------------
    Robert Nelson
    Scientific Officer, Executive Director
    BioAgilytix Laboratories
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer or other entities to which I am affiliated.
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    Original Message