PDA Technical Report 14, Revised 2008, Validation of Column-Based Chromatography Processes for the Purification of Proteins was prepared by members of the PDA Validation of Column-Based Chromatography Processes for the Purification of Proteins Task Force.
Since publication of the original Technical Report No. 14 in 1992, the biotech industry has grown rapidly. Technological
development has resulted in improved pharmaceutical
processing equipment and advances in separation science.
This technical report provides a current industry perspective
and scientific guidance on the validation of column-based
separation processes for the purification of
biopharmaceutical proteins. It is intended to complement PDA
Technical Report No. 42, “Process Validation of Protein
Manufacturing” and to provide more detailed guidance on
validation of the chromatography aspect of the protein
2008, Volume 62, Issue No. S-3.
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Table of Contents:
Click here to download >>> Detailed Table of ContentsINTRODUCTION
GLOSSARY OF TERMS
CHROMATOGRAPHY VALIDATION PREREQUISITES
COLUMN PROCESS VALIDATION