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USP 1049.1 Design of Stability Studies for Biotechnological and Biological Product Dev and Lifecycle Management

  • 1.  USP 1049.1 Design of Stability Studies for Biotechnological and Biological Product Dev and Lifecycle Management

    Community Leadership
    Posted 07-22-2025 13:40

    Of interest to our stability community:  USP has published a draft of a companion chapter to USP <1049> for public comment.  Several members of our community were on the USP expert panel that authored this chapter.  Check it out!

    PF 51(4) USP 1049.1 Design of Stability Studies for Biotechnological and Biological Product Dev and Lifecycle Management



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    Lori McCaig Ph.D.
    Director Global Stability Program Management
    Pfizer, Inc.
    San Jose CA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: USP 1049.1 Design of Stability Studies for Biotechnological and Biological Product Dev and Lifecycle Management

    Community Leadership
    Posted 07-24-2025 15:08

    This is great news! Thanks for posting. 
    Kudos to the Expert Panel for delivering this fantastic chapter. 



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    Tapan Das, Ph.D., FAAPS


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