Zobrazeno 1 - 8
of 8
pro vyhledávání: '"Gianni, Torraca"'
Autor:
Stephanie, Moore, Peter, Masatani, Yasser, Nashed-Samuel, Gianni, Torraca, Michael, Akers, Jeremy, Gastwirt, Chakradhar, Padala, David, Semin
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. :pdajpst.2021.012686
A previously unreported particle type was observed during routine visual vial inspection of a liquid drug product and suspected to be the result of vial delamination. Delamination is the corrosive attack on the interior surface of a glass container r
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bc1aea0a83a5b0927a2da6646f1701b9
https://doi.org/10.5731/pdajpst.2021.012686
https://doi.org/10.5731/pdajpst.2021.012686
Autor:
Michelle Cua, Patricia Meza, Gianni Torraca, Changhuei Yang, Thomas Clark Pearson, Shawn Cao, Daniel Martin
Publikováno v:
J Pharm Sci
Pre-filled syringes (PFSs) are commonly used for parenteral delivery of protein therapeutics. In PFSs, the inner surface of the syringe barrel is typically coated with silicone oil for lubrication. The total amount of silicone oil as well as its dist
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3a10ef82c5b292ea6b0d64ed523d795b
https://europepmc.org/articles/PMC7572663/
https://europepmc.org/articles/PMC7572663/
Publikováno v:
Journal of Pharmaceutical Sciences. 101:1378-1384
Glass particles generated by glass dissolution and delamination of the glass container for pharmaceutical products have become a major issue in the pharmaceutical industry. The observation of glass particles in certain injectable drugs, including sev
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::15ee8cb36ed704275e58ff0710c8f7b4
https://doi.org/10.1002/jps.23048
https://doi.org/10.1002/jps.23048
Publikováno v:
Vibrational Spectroscopy. 50:152-159
Over the last two decades, the number of biopharmaceutical drug candidates entering clinical trials to treat various diseases has dramatically increased. During the manufacturing process of clinical drug candidates, foreign materials may be introduce
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f28b66badbe0e30fe736248148663008
https://doi.org/10.1016/j.vibspec.2008.10.016
https://doi.org/10.1016/j.vibspec.2008.10.016
Publikováno v:
Biophysics for Therapeutic Protein Development ISBN: 9781461443155
A microparticle analysis strategy in therapeutic protein manufacturing NC investigation is outlined for the biopharmaceutical industry. The general approach for NC investigation and the principles of the primary analytical technologies and procedures
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b484b8342acb00413f498db4ca80330b
https://doi.org/10.1007/978-1-4614-4316-2_10
https://doi.org/10.1007/978-1-4614-4316-2_10
Autor:
Wei, Liu, Rob, Swift, Gianni, Torraca, Yasser, Nashed-Samuel, Zai-Qing, Wen, Yijia, Jiang, Aylin, Vance, Anthony, Mire-Sluis, Erwin, Freund, Janice, Davis, Linda, Narhi
Publikováno v:
PDA journal of pharmaceutical science and technology. 64(1)
Particles isolated from a pre-filled syringe containing a protein-based solution were identified as aggregated protein and tungsten. The origin of the tungsten was traced to the tungsten pins used in the supplier's syringe barrel forming process. A t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::0d435250ca1b08c04978569b873a8292
https://pubmed.ncbi.nlm.nih.gov/21501999
https://pubmed.ncbi.nlm.nih.gov/21501999
Autor:
Yasser, Nashed-Samuel, Gianni, Torraca, Dengfeng, Liu, Kiyoshi, Fujimori, Zhongqi, Zhang, Zai-Qing, Wen, Hans, Lee
Publikováno v:
PDA journal of pharmaceutical science and technology. 64(3)
An unexpected, black particle (∼300 microns) was visually observed adhering to the interior shoulder of a prefilled glass syringe containing a biological drug product. The goal of this study was to determine the source, identity, and leachables of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::73401f029bf1c68e0f1ce4c600133f8f
https://pubmed.ncbi.nlm.nih.gov/21502024
https://pubmed.ncbi.nlm.nih.gov/21502024
Autor:
Yasser Nashed-Samuel, Kiyoshi Fujimori, Linda O. Narhi, Joey Pollastrini, Gianni Torraca, Erwin Freund, Monica Pallitto, Cynthia Li, Janice M. Davis, Lisa Donahue, Tony Mire-Sluis, Aylin Vance, Zai-Qing Wen, David Mallard, Grace C. Chu, Wei Liu, Yijia Jiang
Publikováno v:
Journal of pharmaceutical sciences. 98(12)
Tungsten has been associated with protein aggregation in prefilled syringes (PFSs). This study probed the relationship between PFSs, tungsten, visible particles, and protein aggregates. Experiments were carried out spiking solutions of two different
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8fea862122e24172da117334f0a700a4
https://pubmed.ncbi.nlm.nih.gov/19645002
https://pubmed.ncbi.nlm.nih.gov/19645002