Skip to main content

Call for Methods: Call for Somatropin Cell-Based Bioidentity Methods and Participating Laboratories

Type of Posting: General Announcement

Posting Date: 17–Jul–2012

Closing Date: 01–Sep–2012

Expert Committee: Monographs—Biologics & Biotechnology 1

The USP Biologics & Biotechnology Monographs 1 Expert Committee is charged with the identification and qualification of appropriate bioidentity tests for Somatropin drug substances and products. The USP intends to modernize the current bioidentity test in the Somatropin monographs and move them into a new USP chapter, General Chapter <126> Somatropin Bioidentity Tests. The official test uses a rat-based method that is lengthy, variable, and expensive. USP has received a validated cell-based method and cell line for production of a USP Reference Standard and is currently verifying this new method. If you have a validated bioidentity method approved for use with an FDA-approved somatropin that you would like USP to consider for inclusion in this new chapter, please contact Dr. Maura Kibbey, Senior Scientific Liaison ( If you would like to be involved in the collaborative testing of the new USP method and cell line RS, please contact Dr. Mary Crivellone, Senior Reference Standard Scientist (