Zobrazeno 1 - 10
of 54
pro vyhledávání: '"Brent S. Kendrick"'
Publikováno v:
Journal of Pharmaceutical Sciences. 109:2413-2425
A diverse set of analytical tools is required to characterize the complex structural properties of biopharmaceutical products and to ensure their quality, stability, safety, and efficacy. It is generally necessary to demonstrate that such tools are c
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f2d5389f959207883ae0f610b1ba6504
https://doi.org/10.1016/j.xphs.2020.05.012
https://doi.org/10.1016/j.xphs.2020.05.012
Publikováno v:
Journal of Pharmaceutical Sciences. 109:933-936
Protein secondary structures are frequently assessed using infrared and circular dichroism spectroscopies during drug development (e.g., during product comparability and biosimilarity studies, reference standard characterization, etc.) However, there
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d8972d618f8b3e34d9c525b5d33e8765
https://doi.org/10.1016/j.xphs.2019.09.004
https://doi.org/10.1016/j.xphs.2019.09.004
Publikováno v:
Biosimilars ISBN: 9783319996790
Availability of biosimilar drugs in the United States and other regions of the world plays an important role in decreasing drug prices and increasing access to life-enhancing therapies. To ensure safety, efficacy, and bioequivalence of these biologic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::fb8a14de2fa230c664cc83c7a2694baf
https://doi.org/10.1007/978-3-319-99680-6_12
https://doi.org/10.1007/978-3-319-99680-6_12
Publikováno v:
Journal of Pharmaceutical Sciences. 98:3522-3539
Sedimentation velocity analytical ultracentrifugation (SV-AUC) has found application in the biopharmaceutical industry as a method of detecting and quantifying protein aggregates. While the technique offers several advantages (i.e., matrix-free separ
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::eca84847a194f281f66e61ff8dfddd9a
https://doi.org/10.1002/jps.21654
https://doi.org/10.1002/jps.21654
Autor:
Michael R. Stoner, Brent S. Kendrick, Kelly K. Arthur, John P. Gabrielson, Theodore W. Randolph
Publikováno v:
Journal of Pharmaceutical Sciences. 98:50-62
The final formulations of modern pharmaceutical protein products typically contain sugars or sugar alcohols as stabilizers. Migration of these sugars under the influence of an applied gravitational field during sedimentation velocity analytical ultra
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f640b5618d28273e9131717c29c84eda
https://doi.org/10.1002/jps.21403
https://doi.org/10.1002/jps.21403
Autor:
Brent S. Kendrick, Regina M. Murphy
Publikováno v:
Biotechnology Progress. 23:548-552
Interest in the problem of protein misfolding and aggregation has exploded in recent years for two reasons: (1) the sharp rise in the number and volume of therapeutic proteins produced commercially and (2) the recognition of the central role of prote
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ed1a6c2927123c78cff04f468cdfdbb0
https://doi.org/10.1021/bp060374h
https://doi.org/10.1021/bp060374h
Publikováno v:
Analytical Biochemistry. 361:24-30
Sedimentation velocity analytical ultracentrifugation (SV-AUC) has emerged in the biopharmaceutical industry as a technique to detect small quantities of protein aggregates. However, the limits of detection and quantitation of these aggregates are no
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::70f3bb2f640ad5b4e09f57649b540be9
https://doi.org/10.1016/j.ab.2006.11.012
https://doi.org/10.1016/j.ab.2006.11.012
Publikováno v:
Biotechnology and Bioengineering. 98:476-485
High hydrostatic pressures have been used to dissociate non-native protein aggregates and foster refolding to the native conformation. In this study, partial specific volume and adiabatic compressibility measurements were used to examine the volumetr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::edce8f1bb313e3a23aa631e6e32eecef
https://doi.org/10.1002/bit.21398
https://doi.org/10.1002/bit.21398
Publikováno v:
Methods in enzymology. 562
The levels and types of aggregates present in protein biopharmaceuticals must be assessed during all stages of product development, manufacturing, and storage of the finished product. Routine monitoring of aggregate levels in biopharmaceuticals is ty
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::67e8663dbc064714a78ff050f524fe2a
https://pubmed.ncbi.nlm.nih.gov/26412664
https://pubmed.ncbi.nlm.nih.gov/26412664
The levels and types of aggregates present in protein biopharmaceuticals must be assessed during all stages of product development, manufacturing, and storage of the finished product. Routine monitoring of aggregate levels in biopharmaceuticals is ty
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9eef83715c54cb786fc0bbcd68a3163d
https://doi.org/10.1016/bs.mie.2015.06.011
https://doi.org/10.1016/bs.mie.2015.06.011