Zobrazeno 1 - 10
of 19
pro vyhledávání: '"Erwin Freund"'
Autor:
Susanne Atkinson, Andrew Spasoff, Cathal Elliott, Erwin Freund, Adrian Bennis, Linda O. Narhi
Publikováno v:
Journal of pharmaceutical sciences. 107(9)
The requirement for visual inspection of pharmaceuticals has been a compendial expectation for over a century, with some advancement of visible particle control strategies in recent years. Current philosophies include a 100% inspection and an Accepta
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1ef221e99a114a2ec8afe58ddce7acc5
https://pubmed.ncbi.nlm.nih.gov/29859961
https://pubmed.ncbi.nlm.nih.gov/29859961
Autor:
Donn Sederstrom, Daniel Steinmann, Erwin Freund, Elise Schiltz, Christian Schöneich, Theodore W. Randolph, Corrine S. Lengsfeld, Margaret Speed Ricci, John F. Carpenter, Olivier Mozziconacci
Publikováno v:
Journal of Pharmaceutical Sciences. 104:602-611
Industry experience suggests that g-forces sustained when vials containing protein formulations are accidentally dropped can cause aggregation and particle formation. To study this phenomenon, a shock tower was used to apply controlled g-forces to gl
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d39870c1d7fa34b9f2dd413b8894af36
https://doi.org/10.1002/jps.24259
https://doi.org/10.1002/jps.24259
Publikováno v:
Journal of Pharmaceutical Sciences. 98:3290-3301
Tungsten microparticles may be introduced into some pre-filled syringes during the creation of the needle hole. In turn, these microcontaminants may interact with protein therapeutics to produce visible particles. We found that soluble tungsten polya
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5eb99036eeebc674f58b3a02fa55402a
https://doi.org/10.1002/jps.21707
https://doi.org/10.1002/jps.21707
Publikováno v:
Quality by Design for Biopharmaceutical Drug Product Development ISBN: 9781493923151
Quality by Design (QbD) of biopharmaceuticals assumes that desired properties of the final drug product can be predicted with the help of various analytical and characterization methods during the development process. This should be translated into a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::7be8c4f95657b813da4273df00df55fd
https://doi.org/10.1007/978-1-4939-2316-8_20
https://doi.org/10.1007/978-1-4939-2316-8_20
Autor:
Erwin Freund
Publikováno v:
Sterile Product Development ISBN: 9781461479772
This chapter will describe the current state of the art and expectations of performing inspections of drug product with a focus on those defects that are visible to the eye. Visible attributes cover cosmetic and functional defects using both manual a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b5dbc6097ebda73d165d4241d5119033
https://doi.org/10.1007/978-1-4614-7978-9_15
https://doi.org/10.1007/978-1-4614-7978-9_15
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
Publikováno v:
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9e3908779b5e8aff75bda847a4919beb
https://doi.org/10.1002/9780470595886.ch37
https://doi.org/10.1002/9780470595886.ch37
Publikováno v:
Biotechnology and bioengineering. 105(1)
Stainless steel is a ubiquitous surface in therapeutic protein production equipment and is also present as the needle in some pre-filled syringe biopharmaceutical products. Stainless steel microparticles can cause of aggregation of a monoclonal antib
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f95c9ad8300458369d0bbe7c6d37264e
https://pubmed.ncbi.nlm.nih.gov/19725039
https://pubmed.ncbi.nlm.nih.gov/19725039
Autor:
Erwin Freund, Jennifer L. Stevenson, John F. Carpenter, Theodore W. Randolph, David Chiu, Suzanne Sawicki, Jared S. Bee, Koustuv Chatterjee
Therapeutic proteins are exposed to various wetted surfaces that could shed subvisible particles. In this work we measured the adsorption of a monoclonal antibody (mAb) to various microparticles, characterized the adsorbed mAb secondary structure, an
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d3b190c56a0bdb410ebf5f40c253fc83
https://europepmc.org/articles/PMC2749556/
https://europepmc.org/articles/PMC2749556/
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