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BP Consultation: Draft Guidance on rAAV Product Characterisation

  • 1.  BP Consultation: Draft Guidance on rAAV Product Characterisation

    Community Leadership
    Posted 01-30-2026 10:31
    The British Pharmacopoeia released two draft guidance documents for public consultation on characterization of capsid particle populations in rAAV products (attached):
    1. Determination of Vector Genome Identity, Integrity and Encapsidated DNA Impurities
    2. Capsid Protein Characterisation

    Consultation for Characterisation of the Capsid Particle Population in rAAV Products: Determination of Vector Genome Identity, Integrity and Encapsidated DNA Impurities + Capsid Protein Characterisation

    Comments are due March 27, 2026. If any communities would like to respond to this guidance, please contact me by February 6.




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    Allison Radwick Ph.D.
    Sr Regulatory & Policy Comms Mgr
    USP
    Coatesville PA
    [email protected]

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