Interested in learning more about the work of this Expert Committee?
Upcoming Official Meetings
- BIO1 Peptides Expert Committee Meeting, November 8–9, 2017 Rockville, MD
Past Meetings – Executive Summaries
- 4th Peptides Workshop, November 6, 2017 – November 7, 2017. Call for Abstracts now Open!
- Sign up and read the latest edition of the Global Biologics e-Newsletter.
- 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- Modernization of outdated monographs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.
- 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)