BRIEFING

 〈121〉 Insulin Assays. This proposal is based on the version of the chapter official as of December 1, 2020. A new in vitro cell-based bioidentity test for insulin human and insulin aspart is added as an alternative approach to the in vivo bioidentity test using rabbits. This chapter revision proposal contains two options for manufacturers to test the bioidentity of their insulin human or insulin aspart material. One option is the currently official in vivo bioidentity test, and the proposed second option uses an in vitro cell-based procedure. The new In Vitro Cell-Based Bioidentity Test for Insulin Human and Insulin Aspart was validated and approved by the FDA for assuring the potency of a particular manufacturer’s approved products. It is proposed to revise the chapter with the following changes: add the In Vitro Cell-Based Bioidentity Test for Insulin Human and Insulin Aspart.

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

 (BIO2: J. Sun)

 Case ID—SUB-649