In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|April 15, 2003
- 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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Getting Ready for Risk-Based GMPsover 23 years ago
GMP Issues: Breaking Groundover 23 years ago
Guest Editorial: Benchmarking Biotechover 23 years ago
Optimized Nutrient Additives for Fed-Batch Culturesover 23 years ago
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