2020–2025 Biologics Monographs 5 - Advanced Therapies Expert Committee Work Plan

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Focus Areas

  • Gene therapies, gene-modified cell therapies, cellular therapies, mRNA therapies and non-oligonucleotide-based gene editing products such as CRISPR/Cas9.
  • General chapters and reference standards that pertain to the above therapeutic classes

Expert Committee Charge

The Biologics Monographs 5 – Advanced Therapies Expert Committee is responsible for the development and revision of USP–NF general chapters, monographs, and USP Reference Standards in the following therapeutic categories: Gene therapies, gene-modified cell therapies, cellular therapies, mRNA therapies and non-oligonucleotide based gene editing products such as CRISPR/Cas9.

Associated Expert Bodies

  • <1047> Subcommittee
  • Mycoplasma & Rapid Sterility Subcommittee
  • Potency & Comparability Subcommittee
  • Plasmid DNA Expert Panel
  • Joint Subcommittee (Reference Materials)

Standard 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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