Zobrazeno 1 - 10
of 27
pro vyhledávání: '"Kiyoshi, Fujimori"'
Autor:
Yasser Nashed-Samuel, Kiyoshi Fujimori, Hans Lee, Alejandra Gallegos, Kim Li, Jian Liu, Yanxin Luo, Li Qi, Michael Ronk
Publikováno v:
Journal of Pharmaceutical Sciences. 110:3580-3593
Rubber stoppered glass vial systems are widely used as primary containers for storing and delivering therapeutic protein products to patients. Addressing concerns and regulatory expectations related to the risk to biologic drug product quality and pa
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::429cb51acc9ecb27c811bb197a8b5a25
https://doi.org/10.1016/j.xphs.2021.07.015
https://doi.org/10.1016/j.xphs.2021.07.015
Autor:
Hans Lee, Michael Ronk, David J. Semin, Chandra Sekhar, Yasser Nashed-Samuel, Kiyoshi Fujimori, Yanxin Luo
Publikováno v:
Journal of Pharmaceutical Sciences. 109:3378-3385
Control of elemental impurities in the drug products evolved from the generic visual testing of heavy metals as their sulfides to specific elements of toxicological concern in the final drug products by instrumental analysis. The International Counci
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f109ee515fd9c97bac35624487220b96
https://doi.org/10.1016/j.xphs.2020.07.026
https://doi.org/10.1016/j.xphs.2020.07.026
Autor:
Kiyoshi Fujimori, Hans Lee, Yanxin Luo, Jian Liu, Alejandra Gallegos, Yasser Nashed-Samuel, Michael Ronk, Kim Li
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 74:627-643
Prefilled syringes (PFS) are a container and delivery device of choice for storing and administering therapeutic protein products to patients. Addressing concerns and regulatory expectations related to the risk to biologic drug product quality and pa
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e5db05c486f166947c9c74110aeff98a
https://doi.org/10.5731/pdajpst.2019.011379
https://doi.org/10.5731/pdajpst.2019.011379
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 71:50-58
The European Pharmacopeia surface test to analyze the hydrolytic resistance is a common industrial method to understand and ensure the quality of produced glass vials. Hydrolytic resistance is evaluated by calculating the alkalinity of water extract
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7f3a1873258222bd3fe81732ba78cea6
https://doi.org/10.5731/pdajpst.2016.007005
https://doi.org/10.5731/pdajpst.2016.007005
Autor:
Liliana Marghitoiu, Kiyoshi Fujimori, Asher Lower, Gary Rogers, Michael Ronk, Lourdes Perez, Heather Nunn, Yasser Nashed-Samuel, Jian Liu, Matthew R. Hammond, Hans Lee
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 69:49-58
Studies of the extractable profiles of bioprocessing components have become an integral part of drug development efforts to minimize possible compromise in process performance, decrease in drug product quality, and potential safety risk to patients d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c59710d4cc93d3f4692df39022acb64c
https://doi.org/10.5731/pdajpst.2015.01001
https://doi.org/10.5731/pdajpst.2015.01001
Autor:
Kiyoshi Fujimori, Quanzhou Luo, Andrea Hawe, Yasser Nashed-Samuel, Marisa K. Joubert, Wim Jiskoot, Linda O. Narhi, Vibha Jawa, Jette Wypych, Riccardo Torosantucci
To physicochemically characterize and compare monoclonal antibody (mAb) solutions containing aggregates generated via metal catalyzed oxidation (MCO).Two monoclonal IgG2s (mAb1 and mAb2) and one monoclonal IgG1 (rituximab) were exposed to MCO with th
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::37119bd937a6bad910830e7156cf72de
https://doi.org/10.1007/s11095-017-2262-8
https://doi.org/10.1007/s11095-017-2262-8
Autor:
Margaret Speed Ricci, Alison Hair, Kiyoshi Fujimori, Rob Swift, Ananthakrishnan Sethuraman, Vasumathi Dharmavaram, Gary Li, Wendy Jing, Renuka Thirumangalathu, Lejla Brych, Zai-Qing Wen, Gayathri Ratnaswamy, Yasser Nashed-Samuel, Deirdre Murphy Piedmonte
Publikováno v:
Journal of Pharmaceutical Sciences. 103:1104-1114
Visible particles were unexpectedly observed in a neutral-pH placebo formulation stored in glass vials but were not observed in the same formulation composition that contained protein. The particles were identified as silica gel (SiO2) and polysorbat
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::daf8840a3c62389ec1b5cb4cf3debf0b
https://doi.org/10.1002/jps.23871
https://doi.org/10.1002/jps.23871
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 67:670-679
Leachable tungsten is associated with protein aggregation and precipitation in glass prefilled syringes, and this may trigger immunogenicity concerns. Determining the level of leachable tungsten from glass prefilled syringes is critical for assuring
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5ddd6acd039a0b3f7c0966726b11f4e8
https://doi.org/10.5731/pdajpst.2013.00941
https://doi.org/10.5731/pdajpst.2013.00941
Autor:
Kiyoshi Fujimori, Nathan E. Lewis, Julia Bach, Ron Gillespie, Rebecca E. Mccoy, Kenneth M. Prentice, Catherine M. Eakin, Lisa Connell-Crowley
Publikováno v:
mAbs. 5:974-981
Process control of protein therapeutic manufacturing is central to ensuring the product is both safe and efficacious for patients. In this work, we investigate the cause of pink color variability in development lots of monoclonal antibody (mAb) and F
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ce2c6d06ecfccf38cc4d1f777e1d5e4a
https://doi.org/10.4161/mabs.25921
https://doi.org/10.4161/mabs.25921
Publikováno v:
PDA journal of pharmaceutical science and technology. 70(1)
Glass prefilled syringes are increasingly becoming a container of choice for storing and administering therapeutic protein products to patients. Tungsten leaching from a PFS is known to induce protein particle formation, and the source was traced to
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::da52ee1a39fa59d1a887d50336a56803
https://pubmed.ncbi.nlm.nih.gov/26797967
https://pubmed.ncbi.nlm.nih.gov/26797967