2015–2020 Biologics Monographs 3 - Complex Biologics Expert Committee Work Plan

Contact

  • Kevin Carrick, Ph.D., Scientific Liaison – Global Biologics, klc@usp.org
  • Rebecca Potts, Ph.D., Assistant Science & Standards Liaison – Global Biologics, rcp@usp.org
  • Interested in learning more about the work of this Expert Committee?

Download Roster Observe a Meeting

Upcoming Official Meetings

  • SAVE THE DATE!  BIO 3 Expert Committee Meeting in Rockville, MD March 6–7, 2018

Past Meetings – Executive Summaries

Latest Updates

Focus Areas

  • Anticoagulants and protamine, GAGs, carbohydrates, blood and blood products, cells, and tissue monographs and reference standards
  • Selected general chapters that pertain to the anticoagulants and protamine, GAGs, carbohydrates, blood and blood products, cells, and tissue monographs

Expert Committee Charge

The Biologics Monographs 3 – Complex Biologics Expert Committee is responsible for the development and revision of USP–NF monographs and their associated USP Reference Standards in the following therapeutic categories: Anticoagulants and protamine, GAGs, carbohydrates, blood and blood products, cells, and tissue.

Key Issues

  • Work with other Biologics Expert Committees, FDA and stakeholders
    • to improve existing complex biologics monographs
    • to develop new product monographs in the area of coagulation factors
    • on standards for cellular therapeutics

Subgroups and Expert Panels

  • Cell Therapy Topics Working Group
  • Coagulation Factors Expert Panel (coming soon)
  • Factor IX Working Group
  • Low Molecular Weight Heparins Expert Panel
  • Factor VIIa Assay Subcommittee
  • Joint Subcommittee (Reference Materials)

Standards Development