2015–2020 Biologics Monographs 1 - Peptides Expert Committee Work Plan

Contact

Michael Huang, Ph.D., Senior Science & Standards Liaison—Global Biologics, bmh@usp.org
Dale Schmidt, M.S., Science & Standards Liaison—Global Biologics, dls@usp.org

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

Download Roster Observe a Meeting

Upcoming Official Meetings

  • BIO1 Peptides Expert Committee Meeting, November 8–9, 2017 Rockville, MD

Past Meetings – Executive Summaries

Latest Updates

Focus Areas

  • Monographs and reference standards (RS) for synthetic, recombinant, naturally-derived therapeutic peptides under 40 amino acids in length and insulin products
  • Quality control of raw materials used in manufacturing of synthetic peptides
  • Compendial considerations for conjugated and otherwise modified peptides to extend half-life of drug product
  • Selected general chapters that pertain to the synthetic peptide, hormone, and insulin monographs
  • Modernization of outdated monographs
  • Identification and development of new monographs and RS

Expert Committee Charge

The Biologics Monographs 1 – Peptides Expert Committee is responsible for the development and revision of USP-NF monographs and their associated USP Reference Standards in the following categories: Synthetic peptides, hormones, and insulins.

Key Issues

  • Work with other Biologics Expert Committees, FDA and stakeholders to improve existing peptide and insulin monographs and develop new peptide and insulin monographs
  • Conduct workshops relevant to areas of interest to the Expert Committee
  • Transition of animal-based insulin bioassays to cell-based bioassays
  • Transition from recombinant to synthetic drug and regulatory considerations and reference standards needed to support both forms

Subgroups and Expert Panels

  • Glucagon Expert Panel
  • Bivalirudin Working Group
  • Eptifibatide Monograph Subcommittee
  • Exenatide Monograph Subcommittee
  • Triptorelin Monograph Subcommittee
  • Oxytocin/Vasopressin Subcommittee
  • Gonadorelin Acetate Monograph Subcommittee
  • Glatiramer Expert Panel
  • Insulin Expert Panel
  • Joint Subcommittee (Reference Materials)

Standards Development