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Bridging GMP lots of biotherapeutics for bioanalytical assays in Phase 3.

  • 1.  Bridging GMP lots of biotherapeutics for bioanalytical assays in Phase 3.

    Posted 02-11-2025 11:39

    Greetings to the bioanalytical community, 

    Hope to hear some feedback or insights on this topic: 

    In a late-stage phase 3 trials we often need to supply multiple lots of GMP drugs (mAbs in this case) to the clinical sites. What is the standard practice to show lot to lot comparability in the sense of bioanalytical assays? Is it necessary to perform bridging experiments for all the lots used in the clinical study or a CMC issued comparability report would suffice? It may be necessary to bridge the LBA-based PK assays, but what about MSD-based ADA assays? Is it necessary to relabel the new lot of the drug since they are used as reagents and not the actual analytical target? We are committed to perform what is required but curious to see what the current standard practice is. 

    Thanks in advance. 

    Best, 

    Yu-Lu 



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    Yu-Lu Ma
    Research Scientist I
    Viridian Therapeutics
    Franklin MA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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