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Propsed USP Chapter | BioQuality.biz

USP <1106>, a proposed new USP Chapter on Immunogenicity Assays was presented and discussed yesterday at the 2012 National Biotechnology Conference sponsored by AAPS. The moderators were Maura Kibby, Ph.D. from the USP, Anthony Mire-Sluis, Ph.D. from Amgen, and Meena Subramanyam, Ph.D., from Biogen Idec. Topics discussed included:

  • History and Scope of <1106>
  • Why <1106> is needed
  • An Outline of the propsed Chapter
  • Design of cut points for both screening and confirmation assays
  • Assay sensitivity in:
    • the absence of drug
    • the presence of drug
  • Current status and next steps

To see the proposed chapter: www.usppf.com (access to Pharmacopeial Forum is free, after sign-up)

See this month’s BioQuality for a detailed discussion of this important new document. To subscribe: www.bioquality.biz

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