Generic/matrix evaluation of SV40 clearance by anion exchange chromatography in flow-through mode
| Autor: | Yuan Xu, Sherrie Curtis, Gregory S. Blank, Kitty Lee, Kurt Brorson |
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| Rok vydání: | 2003 |
| Předmět: |
Anions
viruses Flow (psychology) Fast flow Process improvement Bioengineering Simian virus 40 Applied Microbiology and Biotechnology Polymerase Chain Reaction Cell Line Matrix (chemical analysis) Robustness (computer science) Animals Bracketing Biological Products Chromatography Ion exchange Chemistry Electric Conductivity Hydrogen-Ion Concentration Chromatography Agarose Chromatography Ion Exchange DNA Viral Spectrophotometry Ultraviolet Viral contamination Drug Contamination Biotechnology |
| Zdroj: | Biotechnology and bioengineering. 84(2) |
| ISSN: | 0006-3592 |
| Popis: | The potential of viral contamination is a regulatory concern for continuous cell line-derived pharmaceutical proteins. Complementary and redundant safety steps, including an evaluation of the viral clearance capacity of unit operations in the purification process, are performed prior to registration and marketing of biotechnology pharmaceuticals. Because process refinement is frequently beneficial, CBER/FDA has published guidance facilitating process improvement by delineating specific instances where the bracketing and generic approaches are appropriate for virus removal validation. In this study, a generic/matrix study was performed using Q-Sepharose Fast Flow (QSFF) chromatography to determine if bracketing and generic validation can be applied to anion exchange chromatography. Key operational parameters were varied to upper and lower extreme values and the impact on viral clearance was assessed using simian virus 40 (SV40) as the model virus. Operational ranges for key chromatography parameters were identified where an SV40 log(10) reduction value (LRV) of >or=4.7 log(10) is consistently achieved. On the basis of the apparent robustness of SV40 removal by Q-anion exchange chromatography, we propose that the concept of "bracketed generic" validation can be applied to this and potentially other chromatography unit operations. |
| Databáze: | OpenAIRE |
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