Zobrazeno 1 - 10
of 19
pro vyhledávání: '"Mary E.M. Cromwell"'
Publikováno v:
Journal of Pharmaceutical Sciences. 104:4170-4184
This study was designed to assess the effects of cooling rate, storage temperature, and formulation composition on trehalose phase distribution and protein stability in frozen solutions. The data demonstrate that faster cooling rates (>100°C/min) re
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9520f2ec380516c8e1ee5b7a83bfa39d
https://doi.org/10.1002/jps.24646
https://doi.org/10.1002/jps.24646
Autor:
Lynne A. Krummen, Brian D. Kelley, Niklas Engler, Raquel Iverson, Gerald Gellermann, Ron Taticek, Christof Finkler, Reed J. Harris, Lynn A. Gennaro, Mary E.M. Cromwell, J. Felix Kepert, Nathan McKnight, Paul Motchnik, Volker Schnaible
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization. 44(5)
Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6b38b658a3d778fd4dbaad2ce6e6806f
https://pubmed.ncbi.nlm.nih.gov/27430904
https://pubmed.ncbi.nlm.nih.gov/27430904
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization. 44(5)
Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::879a10952cca78fb4267189724053a12
https://pubmed.ncbi.nlm.nih.gov/27461127
https://pubmed.ncbi.nlm.nih.gov/27461127
Autor:
Karoline Bechtold-Peters, Jeffrey T. Blue, Hanns-Christian Mahler, Mary E.M. Cromwell, Michel Awwad, Satish K. Singh, Thomas Spitznagel, Doug P. Nesta, Danny K. Chou, Hans-Juergen Krause, Nataliya Afonina, Brian K. Meyer, Linda O. Narhi
Publikováno v:
Journal of Pharmaceutical Sciences. 99:3302-3321
Concern around the lack of monitoring of proteinaceous subvisible particulates in the 0.1-10 microm range has been heightened (Carpenter et al., 2009, J Pharm Sci 98: 1202-1205), primarily due to uncertainty around the potential immunogenicity risk f
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8da6cbebd9afebc1062b8e250b485ee8
https://doi.org/10.1002/jps.22097
https://doi.org/10.1002/jps.22097
Autor:
Robert F. Kelley, Taylor Zhang, Xuan Gao, Junyan A. Ji, Mary E.M. Cromwell, Jun Liu, Kai Zheng, William Mcgreevy, Y. John Wang, Michael W. Laird, Karthik Veeravalli
Publikováno v:
Journal of pharmaceutical sciences. 104(2)
The long serum half-lives of mAbs are conferred by pH-dependent binding of IgG-Fc to the neonatal Fc receptor (FcRn). The Fc region of human IgG1 has three conserved methionine residues, Met252, Met358, and Met428. Recent studies showed oxidation of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ea25bf0f255d66488cf5ce71f36bbc17
https://pubmed.ncbi.nlm.nih.gov/25175600
https://pubmed.ncbi.nlm.nih.gov/25175600
Publikováno v:
Biochemistry. 38:13960-13967
The recombinant humanized antibody (rhuMAb) VEGF has a high affinity for vascular endothelial growth factor and is currently being evaluated in clinical trials as a cancer therapeutic. Under acidic pH and low ionic strength conditions, the antibody w
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7b177b0eea5ccbd9818743765899443e
https://doi.org/10.1021/bi9905516
https://doi.org/10.1021/bi9905516
Autor:
David J. FitzGerald, Terri Wrin, Marian L. McKee, Ann L. Daugherty, Randall J. Mrsny, Joann Vennari, Mary E.M. Cromwell, Charlotte M. Fryling
Publikováno v:
Journal of Biological Chemistry. 273:9951-9958
To develop a candidate vaccine for human immunodeficiency virus, type 1 (HIV-1), chimeric proteins were constructed by inserting sequences derived from the V3 loop of gp120 into a nontoxic form of Pseudomonas exotoxin (PE). Inserts of 14 or 26 amino
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a57b7bb5080679dff707312c82dd6678
https://doi.org/10.1074/jbc.273.16.9951
https://doi.org/10.1074/jbc.273.16.9951
Autor:
Werner Rubas, Mary E.M. Cromwell
Publikováno v:
Advanced Drug Delivery Reviews. 23:157-162
In the past octanol/water partition coefficients (log D 7.4 ) have been used extensively to predict intestinal absorption. More recently flux measurements across confluent monolayers of Caco-2 cells, a human colonic carcinoma cell line, have been int
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::47a141076d093999c07c6a5c659d184f
https://doi.org/10.1016/s0169-409x(96)00433-4
https://doi.org/10.1016/s0169-409x(96)00433-4
Autor:
Mary E.M Cromwell
Publikováno v:
Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition ISBN: 9781841848204
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::21e30b4ea19170b18be06ba10619fdd6
https://doi.org/10.1081/e-ept4-120027028
https://doi.org/10.1081/e-ept4-120027028
Autor:
Sreedhara Alavattam, Mary E.M. Cromwell, Steven J. Shire, Jun Liu, Sandeep Yadav, Barthélemy Demeule
Publikováno v:
Biophysics for Therapeutic Protein Development ISBN: 9781461443155
Development of proteins as pharmaceuticals is more challenging compared to traditional small molecule drugs because of the increased complexity of the chemical and physical stability of protein pharmaceuticals. This necessitates the use of both analy
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4717eacd261041ef23b06e47a1462171
https://doi.org/10.1007/978-1-4614-4316-2_8
https://doi.org/10.1007/978-1-4614-4316-2_8