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Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods
PURPOSE: To predict precision and other performance characteristics of chromatographic purity methods, which represent the most widely used form of analysis in the biopharmaceutical industry. METHODS: We have conducted a comprehensive survey of purity methods, and show that all performance character...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer US
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3497960/ https://www.ncbi.nlm.nih.gov/pubmed/22893253 http://dx.doi.org/10.1007/s11095-012-0836-z |
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author | Apostol, Izydor Kelner, Drew Jiang, Xinzhao Grace Huang, Gang Wypych, Jette Zhang, Xin Gastwirt, Jessica Chen, Kenneth Fodor, Szilan Hapuarachchi, Suminda Meriage, Dave Ye, Frank Poppe, Leszek Szpankowski, Wojciech |
author_facet | Apostol, Izydor Kelner, Drew Jiang, Xinzhao Grace Huang, Gang Wypych, Jette Zhang, Xin Gastwirt, Jessica Chen, Kenneth Fodor, Szilan Hapuarachchi, Suminda Meriage, Dave Ye, Frank Poppe, Leszek Szpankowski, Wojciech |
author_sort | Apostol, Izydor |
collection | PubMed |
description | PURPOSE: To predict precision and other performance characteristics of chromatographic purity methods, which represent the most widely used form of analysis in the biopharmaceutical industry. METHODS: We have conducted a comprehensive survey of purity methods, and show that all performance characteristics fall within narrow measurement ranges. This observation was used to develop a model called Uncertainty Based on Current Information (UBCI), which expresses these performance characteristics as a function of the signal and noise levels, hardware specifications, and software settings. RESULTS: We applied the UCBI model to assess the uncertainty of purity measurements, and compared the results to those from conventional qualification. We demonstrated that the UBCI model is suitable to dynamically assess method performance characteristics, based on information extracted from individual chromatograms. CONCLUSIONS: The model provides an opportunity for streamlining qualification and validation studies by implementing a “live validation” of test results utilizing UBCI as a concurrent assessment of measurement uncertainty. Therefore, UBCI can potentially mitigate the challenges associated with laborious conventional method validation and facilitates the introduction of more advanced analytical technologies during the method lifecycle. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s11095-012-0836-z) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-3497960 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-34979602012-11-15 Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods Apostol, Izydor Kelner, Drew Jiang, Xinzhao Grace Huang, Gang Wypych, Jette Zhang, Xin Gastwirt, Jessica Chen, Kenneth Fodor, Szilan Hapuarachchi, Suminda Meriage, Dave Ye, Frank Poppe, Leszek Szpankowski, Wojciech Pharm Res Research Paper PURPOSE: To predict precision and other performance characteristics of chromatographic purity methods, which represent the most widely used form of analysis in the biopharmaceutical industry. METHODS: We have conducted a comprehensive survey of purity methods, and show that all performance characteristics fall within narrow measurement ranges. This observation was used to develop a model called Uncertainty Based on Current Information (UBCI), which expresses these performance characteristics as a function of the signal and noise levels, hardware specifications, and software settings. RESULTS: We applied the UCBI model to assess the uncertainty of purity measurements, and compared the results to those from conventional qualification. We demonstrated that the UBCI model is suitable to dynamically assess method performance characteristics, based on information extracted from individual chromatograms. CONCLUSIONS: The model provides an opportunity for streamlining qualification and validation studies by implementing a “live validation” of test results utilizing UBCI as a concurrent assessment of measurement uncertainty. Therefore, UBCI can potentially mitigate the challenges associated with laborious conventional method validation and facilitates the introduction of more advanced analytical technologies during the method lifecycle. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s11095-012-0836-z) contains supplementary material, which is available to authorized users. Springer US 2012-08-15 2012 /pmc/articles/PMC3497960/ /pubmed/22893253 http://dx.doi.org/10.1007/s11095-012-0836-z Text en © The Author(s) 2012 https://creativecommons.org/licenses/by/4.0/ This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. |
spellingShingle | Research Paper Apostol, Izydor Kelner, Drew Jiang, Xinzhao Grace Huang, Gang Wypych, Jette Zhang, Xin Gastwirt, Jessica Chen, Kenneth Fodor, Szilan Hapuarachchi, Suminda Meriage, Dave Ye, Frank Poppe, Leszek Szpankowski, Wojciech Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods |
title | Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods |
title_full | Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods |
title_fullStr | Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods |
title_full_unstemmed | Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods |
title_short | Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods |
title_sort | uncertainty estimates of purity measurements based on current information: toward a “live validation” of purity methods |
topic | Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3497960/ https://www.ncbi.nlm.nih.gov/pubmed/22893253 http://dx.doi.org/10.1007/s11095-012-0836-z |
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