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EMA review of ATMP immunogenicity testing prior to entering the clinic

  • 1.  EMA review of ATMP immunogenicity testing prior to entering the clinic

    Posted 10-20-2023 12:24

    EMA reviewed 88 articles and published a review looking at non-animal models for immunogenicity. The announcement notes the creation of a knowledge base, a technical report and executive summary.

    From the announcement: Key findings

    • The majority of the advanced non-animal models have been used to test cell therapy products.
    • A great number of non-animal approaches used to test the immunogenicity of ATMPs were based on in vitro methods that mainly use cells and tissues cultured in the laboratory.
    • In contrast, it was found that computational and mathematical modelling (in silico methods) were less commonly used.

    (Immunogenicity testing for ATMPs)

    EU Science Hub remove preview
    Immunogenicity testing for ATMPs
    The JRC's EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) carried out a study to review the state-of-the-art of advanced non-animal models in use for immunogenicity testing in advanced therapy medicinal products (ATMPs) and selected 88 papers describing innovative models.
    View this on EU Science Hub >


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    Mark Arnold Ph.D., FAAPS
    Westampton, NJ
    [email protected]
    Bioanalytical Solution Integration
    LinkedIn: https://www.linkedin.com/in/markearnoldphd/
    Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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