Biologics Monographs 1–Peptides Expert Committee (BIO1 EC) November 4–5, 2015 USP–U.S

Biologics Monographs 1–Peptides Expert Committee (BIO1 EC) November 4–5, 2015 USP–U.S. Rockville

Executive Summary ______

A quorum was present and Dr. Mike De Felippis, Chair, presided over the Biologics Monographs 1–Peptides Expert Committee (BIO1 EC) meeting. The following is a summary of the actions and key discussion topics that impacted the work of the BIO1 EC, grouped by topic.

1. Approval of Monographs for PF Publication: The EC approved the following monographs for publication in Pharmacopeial Forum (PF): • Goserelin Implants monograph • Leuprolide Acetate monograph • Insulin Human monograph • Insulin Lispro monograph

2. Peptide Monographs Needing Sponsorship: USP is seeking monograph sponsors for the following peptides and peptide products: • Eptifibatide Injection • Teduglutide • Glatiramer Acetate • Teduglutide for Injection • Glatiramer Acetate Injection • Triptorelin Pamoate for • Icatibant Acetate Injectable Suspension • Lanreotide • Ziconotide • Liraglutide • Ziconotide Acetate Injection • Liraglutide Injection

3. Subcommittee Formation: The EC formed Subcommittees with the following initial objectives: • Teriparatide Subcommittee: Address comments on the Teriparatide Injection monograph. • Oxytocin Subcommittee: Address the Oxytocin monograph modernization. • Insulin Cell-Based Assay Joint Subcommittee: (with members of the Biologics Monographs 2–Proteins EC): Consider replacing the Rabbit Blood Sugar Method in General Chapter <121> Insulin Assays with an Insulin Cell-Based Assay. • Eptifibatide Subcommittee: Develop a new Eptifibatide Injection monograph. • Triptorelin Subcommittee: Finalize the Triptorelin monograph for EC approval and publication in PF. • Vasopressin Subcommittee: Propose a plan for the next Vasopressin Reference Standard (RS) replacement lot. • Gonadorelin Subcommittee: Address Gonadorelin Acetate monograph revisions.

4. Expert Panel Formation: The EC recommended that the Council of Experts Chairperson, Dr. Jaap Venema, form an Expert Panel to develop the proposed Glatiramer Acetate monograph, and Dr. Venema provided verbal approval. The EC will obtain formal approval and initiate a Call for Candidates.

5. Collaborative Studies: The EC approved collaborative study plans for the Oxytocin RS continuation lot, Glucagon Receptor Cell Line RS, and Gonadorelin Acetate RS.