2020–2025 Biologics Monographs 1 - Peptides & Oligonucleotides Expert Committee Work Plan

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Focus Areas

  • Monographs and reference standards (RS) for synthetic, recombinant, naturally-derived therapeutic peptides under 40 amino acids in length 
  • Quality control of raw materials used in manufacturing of synthetic peptides
  • Selected general chapters that pertain to peptides and oligonucleotides 
  • Modernization of outdated monographs
  • Identification and development of new monographs and RS

Expert Committee Charge

The Biologics Monographs 1 – Peptides & Oligonucleotides Expert Committee is responsible for the development and revision of USP-NF monographs and their associated USP Reference Standards in peptides and oligonucleotides

Key Issues

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

Associated Expert Bodies

  • Joint Subcommittee (Reference Materials)

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).  
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here

Learn more about the impact of this EC and its Associated Expert Bodies