Monograph Modernization & Monographs Needing Sponsors

As the role of biologic drugs continues to expand in the therapeutic arena, USP is committed to collaborating with scientific leaders in the biopharmaceutical community to update existing and develop new quality standards that support activities in the discovery, development, manufacturing, and distribution of biologics. Learn more about the development and revision process and how you can get involved.

Monograph Modernization

As part of USP’s broader initiative to update and improve its monographs, USP is continuously reviewing all official USP–NF monographs to evaluate the need for modernization of current tests and assays. Below is a sample list of biological monographs for which USP is seeking sponsors to aid and support modernization:

  • Antithrombin III Human
  • Acarbose
  • Papain
  • Gonadorelin Hydrochloride
  • Sagromostim
  • rAlbumim
  • Aprotinin

If you are interested in learning more or participating in these modernization efforts, please contact Daren Tran, Manager, Standards Acquisition, at dtt@usp.org.

Monographs Needing Sponsors

USP is currently looking for marketers and manufacturers of biological products who would like to become sponsors, or donors, to help us develop monograph standards for those products. The following items are on our priority list:

  • Teriparatide
  • Exenatide
  • Bivalirudin
  • Triptorelin
  • Eptifibatide
  • Degarelix
  • Ziconotide
  • Insulin Glargine
  • Fondaparinux
  • Dalteparin Sodium
  • Epoetin
  • Octreotide
  • Factor IX, plasma derived

If you are interested in becoming a sponsor for these items or other biological products, please contact Daren Tran, Manager, Standards Acquisition, at dtt@usp.org.