BRIEFING

 〈123〉 Glucagon Bioidentity Tests. This proposal is based on the version of the chapter official as of April 1, 2025. The Biologics Monographs 1—Peptides and Oligonucleotides Expert Committee is proposing to revise this chapter to remove the Primary Liver Cell Bioidentity Test. When the In Vitro Cell-Based Bioidentity Test was published, USP planned to omit the rat method after multiple manufacturers have been able to demonstrate that the cell-based method is appropriate for all of their glucagon products. This is part of USP's ongoing effort to phase out animal-based assays in favor of modern in vitro testing.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (BIO1: J. Zhang)

 Case ID—SUB-2436