|Articles|April 15, 2003

BioPharm International

  • BioPharm International-04-01-2003
  • Volume 16
  • Issue 4

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

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Getting Ready for Risk-Based GMPs

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GMP Issues: Breaking Ground

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Guest Editorial: Benchmarking Biotech

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Optimized Nutrient Additives for Fed-Batch Cultures

almost 23 years ago

Commercial Production of Transgenic Crops Genetically Engineered to Produce Pharmaceuticals

almost 23 years ago

Inside Washington: GMP Progress Report

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