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  • 1.  Validation method functional assays

    Posted 02-Aug-2023 12:40

    Hello there,

    i have the following question regardless of the functional assay prior to the Clinical trial.
    Do we need to use validated methods for the SPR (FCgamma receptor and IgE binding) for the characterization purpose?



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    Alejandra Cruz
    Innovation Manager
    México
    Mexico
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  • 2.  RE: Validation method functional assays

    Posted 03-Aug-2023 10:15

    Hi Alejandra,

    We have generally not validated characterization methods for monoclonal antibodies which often act through FcyRs, especially in early development. Depending on how important the functional assay is to your API's clinical indication, regulators may require that you further develop the method (including qualification and/or validation) and include it as a release test. If you have other validated potency method(s) on your release testing panel, those should be sufficient for safety/Phase 1 studies, but again if the functional characterization assay in question is important to the API's mechanism of action, regulators will most likely require further development of such functional assays prior to or concurrent with Phase 2.

    Best,

    Marshall



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    Marshall Hoke
    Director of Regulatory Affairs
    Lafayette CO
    United States
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    Original Message


  • 3.  RE: Validation method functional assays

    Posted 07-Aug-2023 05:30

    Hi Alejandra,

    It depends how you use the assay. I had a similar case recently. If the assay is to determine eligibility and how patients are diagnosed and treated then you will have problems obtaining approval for unvalidated assay. If you use it for other purposes then it may be easier to get it approved in USA. In EU you cannot use IVDs (this is the category your assay falls into) which are not CE marked for drug clinical trials because they will be considered investigational.  

    Have a great week,

    Olga



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    Olga Peycheva
    Regulatory and Study Start Up Specialist
    Solutions OP Ltd
    olga.peycheva@solutionsop.co.uk
    United Kingdom
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    Original Message


  • 4.  RE: Validation method functional assays

    Posted 07-Aug-2023 15:25

    I'm not sure what you mean by "functional assay". If you are talking about your potency assay, some amount of validation/qualification is expected, just how far you have to go depends on what phase you're in. We don't usually use SPR for that. If you're talking about assays looking at Fc effector function, we consider those characterization assays and don't do formal validation but you need to have some amount of confidence in the method. If you're talking about something that you are using for clinical purposes (inclusion/exclusion, diagnosis, treatment decisions, etc.) then that's an in-vitro diagnostic (IVD) and that needs to be validated (but I'm not an expert in that). The above generally applies to US/EU/CA/UK but the details may vary slightly, particularly for an IVD.

    Since you specifically mentioned characterization... we don't validate characterization methods but we do have some amount of data to provide confidence that the assay is showing what you want it to show.

    Hope that helps. 



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    Rachel Thornton
    Director
    Smyrna GA
    United States
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    Original Message


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