Bio Assays - Commentary – First Supplement to USP 35-NF 30

Amongst others, the USP published the received comments and responses to General Chapter/Section: <1032> Design and Development of Biological Assays in the Commentary – First Supplement to USP 35-NF 30.

The USP received 13 comments to different parts of this chapter. Comments to the following topics are included:

  • Necessary Harmonization with compendial references e.g. European Pharmacopoiea
  • Helpful case study examples that illustrate the application
  • The need that the assay acheive a specific observable response
  • Assessment of similarity using the entire concentration-response curve, including the asymptotes.
  • Potency assay for assessment of stability
  • Need of documenting the source of assay's cell line

The complete comments can be found at Commentary – First Supplement to USP 35-NF 30.

In this respect you may also want to pay attention to ECA's New Education Course on "Bioassays, and Bioanalytics" from 27-28 March 2012 in Copenhagen, Denmark.

Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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