Zobrazeno 1 - 10
of 60
pro vyhledávání: '"Miguel, Saggu"'
Autor:
Bingchuan Wei, Nicholas Woon, Lu Dai, Raphael Fish, Michelle Tai, Winode Handagama, Ashley Yin, Jia Sun, Andrew Maier, Dana McDaniel, Elvira Kadaub, Jessica Yang, Miguel Saggu, Ann Woys, Oxana Pester, Danny Lambert, Alex Pell, Zhiqi Hao, Gordon Magill, Jack Yim, Jefferson Chan, Lindsay Yang, Frank Macchi, Christian Bell, Galahad Deperalta, Yan Chen
Publikováno v:
mAbs, Vol 14, Iss 1 (2022)
Rapid release of biopharmaceutical products enables a more efficient drug manufacturing process. Multi-attribute methods that target several product quality attributes (PQAs) at one time are an essential pillar of the rapid-release strategy. The nove
Externí odkaz:
https://doaj.org/article/35d74feefc4744f0aa083c2c0827e7e8
Autor:
Aadithya Kannan, Jamie Giddings, Shrenik Mehta, Tiffany Lin, Anthony Tomlinson, Kyle Ritchie, Ian Shieh, Miguel Saggu, Nidhi Doshi
Publikováno v:
Pharmaceutical Research. 39:563-575
Polysorbates (PS) contain polyoxyethylene (POE) sorbitan/isosorbide fatty acid esters that can partially hydrolyze over time in liquid drug products to generate degradants and a remaining intact PS fraction with a modified ester distribution. The deg
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a6321cd3827aa74bb2b52b436d4bca7a
https://doi.org/10.1007/s11095-022-03217-x
https://doi.org/10.1007/s11095-022-03217-x
Autor:
Srivalli N, Telikepalli, Michael J, Carrier, Dean C, Ripple, Greg, Barnett, Ashwinkumar, Bhirde, Donna, Bolton, George M, Bou-Assaf, Erica, Ferrari, Scott, Leigh, Sophia, Levitskaya-Seaman, Tim, Menzen, Felix, Nikels, Anna, Riley, Miguel, Saggu, Neha, Sahni, Eric, Vernooij, Klaus, Wuchner
Publikováno v:
AAPS PharmSciTech. 24
Visible protein-like particle standards may improve visual inspection and/or appearance testing practices used in the biotechnology industry. They may improve assay performance resulting in better alignment and more standardized training among differ
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6530a496cf1c7a927f12e4ab8426f063
https://doi.org/10.1208/s12249-022-02457-9
https://doi.org/10.1208/s12249-022-02457-9
Autor:
Shawn Cao, Vakhtang Loladze, Dennis T. Yang, Tapan K. Das, Klaus Wuchner, Linda O. Narhi, George M. Bou-Assaf, Anacelia Rios, Friederike Junge, Ankit R. Patel, Valentyn Antochshuk, Stanley C. Kwok, Nataliya Afonina, Miguel Saggu, Mario Hubert, Parag Kolhe, Luis Montrond
Publikováno v:
Journal of Pharmaceutical Sciences. 109:830-844
One of the major product quality challenges for injectable biologics is controlling the amount of protein aggregates and particles present in the final drug product. This article focuses on particles in the submicron range (2 μm). A cross-industry c
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a4ddcc7a803679c340231f989383fce7
https://doi.org/10.1016/j.xphs.2019.10.025
https://doi.org/10.1016/j.xphs.2019.10.025
Autor:
Bingchuan Wei, Nicholas Woon, Lu Dai, Raphael Fish, Michelle Tai, Winode Handagama, Ashley Yin, Jia Sun, Andrew Maier, Dana McDaniel, Elvira Kadaub, Jessica Yang, Miguel Saggu, Ann Woys, Oxana Pester, Danny Lambert, Alex Pell, Zhiqi Hao, Gordon Magill, Jack Yim, Jefferson Chan, Lindsay Yang, Frank Macchi, Christian Bell, Galahad Deperalta, Yan Chen
Publikováno v:
mAbs
article-version (VoR) Version of Record
mAbs, Vol 14, Iss 1 (2022)
article-version (VoR) Version of Record
mAbs, Vol 14, Iss 1 (2022)
Rapid release of biopharmaceutical products enables a more efficient drug manufacturing process. Multi-attribute methods that target several product quality attributes (PQAs) at one time are an essential pillar of the rapid-release strategy. The nove
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bb5a730114fbc81497f1e82415fb3966
https://doi.org/10.1080/19420862.2021.2007564
https://doi.org/10.1080/19420862.2021.2007564
Autor:
Franziska Schleinzer, Dennis T. Yang, Dean C. Ripple, Nazar Filonov, Pascal Chalus, Tapan K. Das, Kurt D. Benkstein, Ashwinkumar A. Bhirde, Stefan Romeijn, Fook Chiong Cheong, Sambit R. Kar, Laura A. Philips, Christine Probst, Adam D. Grabarek, Nicole S. Gill, Maciej Jarzebski, Yoen Joo Kim, David L. Duewer, Miguel Saggu, Andrew D. Hollingsworth, Gurusamy Balakrishnan, Judith Hadley, Vikram Kestens, Yannic Ramaye, Anja Matter, Wesley W. Howard, Theodore W. Randolph, Ngoc Do, Jan Kuba Tatarkiewicz, David G. Grier, Heather Anne Wright, Patrick Garidel, Atanas Koulov, Wim Jiskoot, Jared R. Snell, Harshit Khasa
Publikováno v:
J Pharm Sci
Journal of Pharmaceutical Sciences
Journal of Pharmaceutical Sciences
The measurement of polydisperse protein aggregates and particles in biotherapeutics remains a challenge, especially for particles with diameters of ≈ 1 µm and below (sub-micrometer). This paper describes an interlaboratory comparison with the goal
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ebec099deb60130fdbf19d1d6774ab17
https://europepmc.org/articles/PMC9912188/
https://europepmc.org/articles/PMC9912188/
Publikováno v:
The Journal of Physical Chemistry B. 123:1527-1536
The origin of unidirectional electron transfer in photosynthetic reaction centers (RCs) has been widely discussed. Despite the high level of structural similarity between the two branches of pigments that participate in the initial electron transfer
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6f9e344a95225fd3a34cc7688842aafe
https://doi.org/10.1021/acs.jpcb.8b11458
https://doi.org/10.1021/acs.jpcb.8b11458
Autor:
Steve Russell, Wenqiang Liu, Aadithya Kannan, Tamanna Shobha, Kyle Ritchie, Anthony Tomlinson, Miguel Saggu, Stephen Rumbelow, Jamie Giddings, Rosalynn Taing, Kathrin Gregoritza, Nidhi Doshi, Sandeep Yadav, Victor Nicoulin, Jeff Chu, Si Kai Cai, Lin Luis
Publikováno v:
Pharmaceutical research. 38(9)
To evaluate a modified high purity polysorbate 20 (RO HP PS20)—with lower levels of stearate, palmitate and myristate esters than the non-modified HP PS20—as a surfactant in biopharmaceutical drug products (DP). RO HP PS20 was designed to provide
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2a21df0590584752abfffc3de701c783
https://pubmed.ncbi.nlm.nih.gov/34495486
https://pubmed.ncbi.nlm.nih.gov/34495486
Publikováno v:
Protein Instability at Interfaces During Drug Product Development ISBN: 9783030571764
Biologics subjected to interfacial stress can generate a diverse assortment of aggregated species ranging in size from dimers and other soluble aggregates, through subvisible or micrometer-sized particles, to particles in the hundreds of micrometers
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::471e040ed28884ef66301c6e2b23cdf7
https://doi.org/10.1007/978-3-030-57177-1_8
https://doi.org/10.1007/978-3-030-57177-1_8
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