Zobrazeno 1 - 10
of 25
pro vyhledávání: '"Barthélemy Demeule"'
Publikováno v:
Molecular Pharmaceutics. 17:2345-2353
Polysorbates (PS) are commonly used surfactants in biopharmaceutical protein formulations. However, they are susceptible to a variety of degradation pathways, including chemical hydrolysis, oxidation, and enzymatic hydrolysis. Polysorbates are also h
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3a68591758316d64a75e17a121f3a36b
https://doi.org/10.1021/acs.molpharmaceut.0c00093
https://doi.org/10.1021/acs.molpharmaceut.0c00093
Autor:
Gautham K. Rao, Stephen P. Schauer, Edmond Teng, Joseph Bravo, Reina N. Fuji, Andrea Pfeifer, Yong Ying, Kimberly Scearce-Levie, Jessica Couch, Hilda Solanoy, Paul T. Manser, Andreas Muhs, Han Lin, Daniela Bumbaca Yadav, Oded Foreman, Dongping He, James A. Ernst, Flavia Brunstein, Hai Ngu, Michael C. M. Kwok, Maria Pihlgren, Oskar Adolfsson, Mira Blendstrup, William B. Smith, Priya Chandra, Akash Datwani, Michael Keeley, Danielle DiCara, Robert Brendza, Yanmei Lu, Julien Lafrance-Vanasse, Corinne Foo-Atkins, Jasvinder K. Atwal, Isidro Hötzel, Seung-Hye Lee, Kristin R. Wildsmith, Ruby Chan, Helen Booler, Rich Erickson, Barthélemy Demeule, Geoffrey A. Kerchner, Wilman Luk, Gai Ayalon
Publikováno v:
Science Translational Medicine. 13
Tau has become an attractive alternative target for passive immunotherapy efforts for Alzheimer's disease (AD). The anatomical distribution and extent of tau pathology correlate with disease course and severity better than other disease markers to da
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5c8226f0212aa58c81fd5ec5abd2b2f7
https://doi.org/10.1126/scitranslmed.abb2639
https://doi.org/10.1126/scitranslmed.abb2639
Autor:
Daniel Kammerer, Linda Jiang, Michelle Tai, Barthélemy Demeule, Miguel Saggu, Nina Xiao, Purnendu K. Nayak, Anthony Tomlinson
Publikováno v:
Journal of pharmaceutical sciences. 110(3)
In recent years, there has been increased scrutiny on the presence and formation of product-related particles in biopharmaceutical formulations. These types of particles, originating from the degradation of the active pharmaceutical ingredient or the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::affc21cfdbf6b4e77586c4ece1e8ed06
https://pubmed.ncbi.nlm.nih.gov/33271136
https://pubmed.ncbi.nlm.nih.gov/33271136
Autor:
Barthélemy Demeule, Lin Zhang, Christian Schӧneich, Olivier Mozziconacci, Sandeep Yadav, Y. John Wang
Publikováno v:
Pharmaceutical Research. 34:84-100
To investigate the mechanisms of polysorbate (PS) degradation with the added objective of differentiating the hydrolysis and oxidation pathways. Ultra-performance liquid chromatography mass spectrometry (UPLC-MS) was utilized to characterize all-laur
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ae2841feff30e3fa6db6c3dd6d931aef
https://doi.org/10.1007/s11095-016-2041-y
https://doi.org/10.1007/s11095-016-2041-y
Publikováno v:
Journal of Pharmaceutical Sciences. 105:1667-1675
The International Conference on Harmonization Q8 (R2) includes a requirement that "Critical formulation attributes and process parameters are generally identified through an assessment of the extent to which their variation can impact the quality of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a83cc85e7f792c80377923fa06daa25d
https://doi.org/10.1016/j.xphs.2016.02.013
https://doi.org/10.1016/j.xphs.2016.02.013
Publikováno v:
Molecular Pharmaceutics. 12:3805-3815
Polysorbate 20 (PS20), a commonly used surfactant in biopharmaceuticals, showed degradation upon long-term (∼18-36 months) storage of two monoclonal antibody (mAb, mAb-A, and mAb-B) drug products at 2-8 °C. The PS20 degradation resulted in the acc
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::336bf79bc78220d4144a8be81dc7cfe4
https://doi.org/10.1021/acs.molpharmaceut.5b00311
https://doi.org/10.1021/acs.molpharmaceut.5b00311
Publikováno v:
Molecular Pharmaceutics. 12:3792-3804
The purpose of this work was to determine the aqueous solubilities at 2-8 °C of the major free fatty acids (FFAs) formed by polysorbate 20 (PS20) degradation and identify possible ways to predict, delay, or mitigate subsequent particle formation in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7f080ecbd310386b2885102263edb441
https://doi.org/10.1021/acs.molpharmaceut.5b00310
https://doi.org/10.1021/acs.molpharmaceut.5b00310
Autor:
Napoleone Ferrara, Mehraban Khosraviani, Barthélemy Demeule, Eric S. Day, Steven J. Shire, Sandeep Yadav, Germaine Fuh, Lanlan Yu, Jun Liu, Jihong Yang, Eric Wakshull, Xiangdan Wang
Publikováno v:
Molecular pharmaceutics, vol 11, iss 10
The objectives of this study were to evaluate the relative binding and potencies of three inhibitors of vascular endothelial growth factor A (VEGF), used to treat neovascular age-related macular degeneration, and assess their relevance in the context
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::96edbc01348a8aa7add5e09f3db9933d
https://doi.org/10.1021/mp500160v
https://doi.org/10.1021/mp500160v
Autor:
Thomas M. Scherer, James Andya, Yatin R. Gokarn, Barthélemy Demeule, Sonoko Kanai, Sandeep Yadav, Steven J. Shire, Jun Liu
Publikováno v:
Biophysical Reviews. 5:121-136
Early development of protein biotherapeutics using recombinant DNA technology involved progress in the areas of cloning, screening, expression and recovery/purification. As the biotechnology industry matured, resulting in marketed products, a greater
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1083b4459742be33a09046cf269ec649
https://doi.org/10.1007/s12551-013-0109-z
https://doi.org/10.1007/s12551-013-0109-z
Autor:
Pin Yee Wong, Alavattam Sreedhara, Zephania W. Kwong Glover, Barthélemy Demeule, Sandeep Yadav, Lynn A. Gennaro
Publikováno v:
Journal of Pharmaceutical Sciences. 102:794-812
The physical/chemical stability and potential interactions after diluting two immunoglobulin G1 monoclonal antibodies (mAb), pertuzumab (Perjeta®) and trastuzumab (Herceptin®), in a single intravenous (i.v.) infusion bag containing 0.9% saline (NaC
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6714bc3983e5e03e2bef06f409135482
https://doi.org/10.1002/jps.23403
https://doi.org/10.1002/jps.23403