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

Stephen Moore;John Dougherty;Rohin Mhatre;

Publication

Article

April 15, 2003

BioPharm International

BioPharm International-04-01-2003

Volume16

Issue 4

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

Author(s):

Stephen Moore,John Dougherty

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.

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Articles in this issue

Virus Inactivation in the 1990s and into the 21st Century

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

Getting Ready for Risk-Based GMPs

GMP Issues: Breaking Ground

Guest Editorial: Benchmarking Biotech

Optimized Nutrient Additives for Fed-Batch Cultures

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