Using Peptide Maps as Identity and Purity Tests for Lot Release Testing of Recombinant Therapeutic Proteins

by John Dougherty, Eli Lilly and Company, Rohin Mhatre, Biogen, Inc., and Stephen Moore, CDER FDA and biopharmaceutical industry stakeholders reach consensus on critical issues related to the use of peptide maps as identity tests for proteins and on their usefulness for lot release tests. The results of that discussion are presented here.