2015–2020 Biologics Monographs 2 - Proteins Expert Committee Work Plan

Contact

Rebecca Potts, Ph.D., Assistant Science and Standards Liaison–Global Biologics, rcp@usp.org

Interested in learning more about the work of this Expert Committee?

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Upcoming Official Meetings

Past Meetings – Executive Summaries

Latest Updates

Focus Areas

  • Monographs and Reference Standards (RSs) for recombinant and naturally derived proteins, including therapeutic proteins, monoclonal antibodies, protein hormones, cytokines, enzymes, and complex extracts
  • Selected general chapters that pertain to monographs for therapeutic proteins, monoclonal antibodies, protein hormones, cytokines, enzymes, and complex extract
  • Modernization of outdated monographs
  • Identification and development of new monographs and RSs

Expert Committee Charge

The Biologics Monographs 2 – Proteins Expert Committee is responsible for the development and revision of USP - NF monographs and their associated USP Reference Standards in the following therapeutic categories: Therapeutic proteins, monoclonal antibodies, protein hormones, cytokines, enzymes, and complex extracts.

Key Issues

  • Collaborate with other Biologics Expert Committees, FDA and stakeholders to improve existing monographs and develop new protein product monographs and Reference Standards
  • Conduct workshops relevant to areas of interest to the Expert Committee

Subgroups and Expert Panels

  • Enzymes Expert Panel
  • Fc Function Assays Expert Panel
  • Interferon beta-1a Subcommittee
  • Pegfilgrastim-Filgrastim Subcommittee
  • Joint Subcommittee (Reference Materials)

Standards Development