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USP 1049.1 Design of Stability Studies for Biotechnological and Biological Product Development

  • 1.  USP 1049.1 Design of Stability Studies for Biotechnological and Biological Product Development

    Posted 07-25-2025 15:39

    Dear All - 

    As an FYI, the biological stability companion chapter to the USP 1049, (1049.1) has been published for comment with the commenting period open until 30 Sept 2025.

    There is a comprehensive on-demand webinar on the USP site, which you can sign up for after creating an account if you don't have one already.

    Joan



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    Joan Korth-Bradley Pharm.D., Ph.D., FAAPS
    Distinguished Scientist
    Vivpro
    Lower Gwynedd 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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