PDA TR 14
2008
PDA Technical Report No. 14 (TR 14) Validation of Column-Based Chromatography Processes for the Purification of Proteins
- Format:
- Language(s) :
- Published :
- English
- 09/01/2008
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 purification process.
PDA TR 14 | |
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STANDARD INFO: | |
Standard Name | PDA TR 14 |
Scope | PDA Technical Report No. 14 (TR 14) Validation of Column-Based Chromatography Processes for the Purification of Proteins |
Publisher | PDA - Parenteral Drug Association |
Languages | English |
State | |
Publication Year | 2008 |
Most recent Version | MOST RECENT |
Whether to be replaced | |
Addendum | |
FILE INFO: | |
File Size | 1 file , 730 KB |
ISBN(s) | 9780939459223 |
Number of Pages | 44 |
Published | 09/01/2008 |
PDA TR 14 | ||
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History | Publisher Year | |
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