Zobrazeno 1 - 5
of 5
pro vyhledávání: '"Amber Haynes Fradkin"'
Autor:
John F. Carpenter, Amber Haynes Fradkin, Natalia Markova, Judith Hadley, Aaron B. Krueger, Philip P. Cheney
Publikováno v:
Journal of Pharmaceutical Sciences. 108:1675-1685
Characterizing and quantifying subvisible particles in protein drug products is critical to ensuring product quality. A variety of analytical methods are used to detect and make meaningful measurements of subvisible particles. Resonant mass measureme
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4bf5061f69a292a74ad15785100b63bc
https://doi.org/10.1016/j.xphs.2018.12.017
https://doi.org/10.1016/j.xphs.2018.12.017
Publikováno v:
Journal of pharmaceutical sciences. 109(5)
Evaluating a particle profile for parenteral drug products is a well-known challenge due to inevitable variability of results with limited accuracy to actual particle levels present in the product, especially in the subvisible particulate (SbVP) rang
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2cc0ae2baca8e6f1b160cb2411429839
https://pubmed.ncbi.nlm.nih.gov/32017902
https://pubmed.ncbi.nlm.nih.gov/32017902
Autor:
Amber Haynes Fradkin, Stephen P. Eisenberg, Mary S. Rosendahl, Carl S. Boand, Theodore W. Randolph
Publikováno v:
Biotechnology Progress. 26:743-749
We expressed recombinant murine growth hormone (rmGH) in E. coli as a cost-effective way to produce large quantities (gram scale) of the protein for use in murine studies of immunogenicity to therapeutic proteins. High hydrostatic pressure was used t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::44f4e76dda4f004432ef4ea94eb033e7
https://doi.org/10.1002/btpr.393
https://doi.org/10.1002/btpr.393
Autor:
Christian Schöneich, Olivier Mozziconacci, John F. Carpenter, Theodore W. Randolph, Amber Haynes Fradkin
Publikováno v:
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V. 87(2)
During manufacturing, therapeutic proteins may be exposed to ultraviolet (UV) radiation. Such exposure is of concern because UV radiation may cause photooxidative damage to proteins, which in turn could lead to physical changes such as aggregation an
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::89216f21e66a45b080f318542248389e
https://pubmed.ncbi.nlm.nih.gov/24758742
https://pubmed.ncbi.nlm.nih.gov/24758742
Publikováno v:
Journal of pharmaceutical sciences. 100(11)
Unwanted immune responses to parenterally administered therapeutic proteins pose serious safety and economic risks, but the mechanism(s) by which these responses are generated are unknown. We measured immune responses to aggregates of recombinant mur
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::047c465464bfe58bbedceeb4c5032216
https://pubmed.ncbi.nlm.nih.gov/21721003
https://pubmed.ncbi.nlm.nih.gov/21721003