2020–2025 Biologics Monographs 2 - Proteins Expert Committee Work Plan

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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  • Modernization of outdated monographs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

Associated Expert Bodies

  • Insulin Expert Panel
  • Coagulation Factor Expert Panel
  • MAM Expert Panel
  • Host Cell Protein Expert Panel
  • Trace Metal Expert Panel
  • Enzymes Expert Panel
  • Interferon beta-1a Subcommittee
  • Pegfilgrastim-Filgrastim Subcommittee
  • Joint Subcommittee (Reference Materials)
  • Glycan and Glycan Analysis Joint Subcommittee

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

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