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  • Influence of PH, Buffer Species, and Storage Temperature On Physicochemical Stability of A Humanized Monoclonal Antobody LA298

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    Gabriel F Rueda
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    Influence of pH, buffer species, and storage temperature on physicochemical stability of a humanized monoclonal antobody LA298

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    22 views6 pages

    Influence of PH, Buffer Species, and Storage Temperature On Physicochemical Stability of A Humanized Monoclonal Antobody LA298

    Uploaded by

    Gabriel F Rueda

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 6
    ‘Availabe online at wwwwsciencedirectcom scrence Goinecr- Intemational Jounal of Pharmaceutics 308 (2006) 46-51 iresnationatouenat oF PHARMACEUTICS, -worelseviercomocaelphaem Influence of pH, buffer species, and storage temperature on physicochemical stability of a humanized monoclonal antibody LA298 Jack Y. Zheng*, Linda J. Janis Pharmaceutical Sciences R&D. Lilly Research Laboratories Bl Lilly and Company. Lill Corporate Center: Indianapolis, IN 46288, United Sates Received 18 March 2005; recived in evised form 10 October 208: accepted 10 October 2008, ‘Available online 28 Noverber 2005 Abstract The purpose ofthis work is to study the effect of pH, buffer species, and temperature on the physicochemical stability ofa humanized monoclonal antibody LA298, The study was carried out in solution state ofthe antibody inthe presence of different buffer species at different pH values and storage temperature. No significant changes in total protein content were observed for any ofthe solutions with different buffers at different pH values when stored for 8 weeks at both $°C and 25 °C or at 37°C for I week. Known asparagines (Asn$5) deamidation of LA298 was found tobe

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