PDA TR 14

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PDA TR 14

2008

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PDA Technical Report No. 14 (TR 14) Validation of Column-Based Chromatography Processes for the Purification of Proteins

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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
STANDARD INFO:
Standard NamePDA TR 14
ScopePDA Technical Report No. 14 (TR 14) Validation of Column-Based Chromatography Processes for the Purification of Proteins
PublisherPDA - Parenteral Drug Association
LanguagesEnglish
State
Publication Year2008
Most recent VersionMOST RECENT
Whether to be replaced
Addendum
FILE INFO:
File Size1 file , 730 KB
ISBN(s)9780939459223
Number of Pages44
Published09/01/2008
PDA TR 14
HistoryPublisher Year

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