Zobrazeno 1 - 10
of 17
pro vyhledávání: '"Michael E. Wiebe"'
Autor:
Andrea L, Koenigsberg, Veronica, Fowler, Reuben, Domike, Audrey, Brussel, Paul W, Barone, Flora J, Keumurian, James, Leung, Michael E, Wiebe, Michael T, Brewer, Shawn, Chan, Nicolas, Dumey, Anne, Fournillier, Marcella, Goodnight, Johanna, Kindermann, Richard, Leavy, Buyoung, Lee, Stefan, Minning, Marie, Murphy, Eric, Myers, Armen, Nahabedian, Kavita, Nanda, Sandi, Parriott, G K, Raju, Ciaran, Scallan, Stephanie, Schoch, Joe, Shiminsky, Bonnie, Shum, Sebastian, Teitz, Bernice, Westrek, Stacy, Springs
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 77:115-132
Some members of MIT's Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) previously published content on the ″Quality Risk Management in the Context of Viral Contamination″ which described tools, procedures, and methodolog
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5b9140b063894d389a33167c931386f0
https://doi.org/10.5731/pdajpst.2021.012691
https://doi.org/10.5731/pdajpst.2021.012691
Autor:
Robert Kiss, Jacob Hoffman, Paul W. Barone, Joleen Su, Houman Dehghani, Shelley Alvarado, Jonathan Rice, Martina Kopp, Marie Murphy, Mark Bailey, Stacy L. Springs, Michael E. Wiebe, Dayue Chen
Publikováno v:
Biotechnology and Bioengineering. 118:2967-2976
In recent years, high temperature short time (HTST) treatment technology has been increasingly adopted for medium treatment to mitigate the potential risk of viral contamination in mammalian cell culture GMP manufacturing facilities. Mouse minute vir
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::23db0f2ac9968794d468c5e1539fcfa4
https://doi.org/10.1002/bit.27805
https://doi.org/10.1002/bit.27805
Autor:
Rob Ballard, Stacy L. Springs, Audrey Brussel, Michael E. Wiebe, Flora J. Keumurian, James C. Leung, Paul W. Barone, Nguyen Ly, Sheldon Mink, Ian Hart, Christopher F. Dowd, Johanna Kindermann, Lionel Gerentes, Kerstin Nöske, Stephen Avgerinos, Stefan Minning, Bonnie Shum, Philip Clark, Jurgen Mullberg, Sandi Parriott, Marie Murphy
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 73:191-203
Appropriate segregation within manufacturing facilities is required by regulators and utilized by manufacturers to ensure that the final product has not been contaminated with 1) adventitious viruses, 2) another pre-/ post-viral clearance fraction of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bc67d7dc7edee6f8547f3e4ca45b7e15
https://doi.org/10.5731/pdajpst.2018.008862
https://doi.org/10.5731/pdajpst.2018.008862
Principles of process validation are extremely powerful tools in assurance of product quality. They are especially useful for reducing those risks not easily measured routinely during production. When combined with effective process and facility desi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9cb43874c12a92329e83505571f0f2a9
https://doi.org/10.1201/9780203749166-19
https://doi.org/10.1201/9780203749166-19
Autor:
Mark Plavsic, Lionel Gerentes, Dan Gold, Jurgen Mullberg, Richard Snyder, James C. Leung, James F. Bouressa, Jacqueline Wolfrum, Richard Schicho, Anthony J. Sinskey, Robert Kiss, Michael Ruffing, Audrey Brussel, Houman Dehghani, Laurent Mallet, Paul W. Barone, Marie Murphy, Mark Moody, David J. Roush, Serge Monpoeho, Ming Chong, Nathan J. Roth, Yuling Li, Daniel Stark, Flora J. Keumurian, Chun Zhang, Dayue Chen, Christian Menzel, René Labatut, Thomas R. Kreil, James Gilbert, Michael E. Wiebe, Islam T. M. Hussein, Stacy L. Springs
Publikováno v:
Prof. Sinskey
Recombinant protein therapeutics, vaccines, and plasma products have a long record of safety. However, the use of cell culture to produce recombinant proteins is still susceptible to contamination with viruses. These contaminations cost millions of d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c8f7da6fec6853fca623e33fdbb5d6f7
https://pubmed.ncbi.nlm.nih.gov/32341561
https://pubmed.ncbi.nlm.nih.gov/32341561
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 65:544-546
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Mic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cb6789d905102146228ec2cb01561d0c
https://doi.org/10.5731/pdajpst.2011.00817
https://doi.org/10.5731/pdajpst.2011.00817
Autor:
Michael E. Wiebe, Kathryn E. King
Publikováno v:
PDA journal of pharmaceutical science and technology. 65(6)
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Mic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b755f7c140f77142acb4b206e6627958
https://pubmed.ncbi.nlm.nih.gov/22294602
https://pubmed.ncbi.nlm.nih.gov/22294602
Publikováno v:
Virology. 110:197-201
Ten temperature-sensitive mutants of Venezuelan encephalitis virus were derived from a hamster-virulent strain by treatment with N -methyl- N′ -nitro- N -nitrosoguanidine. Three mutants were relatively thermolabile, and four were RNA − . No mutan
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::101bd4bfb652115a4f72fa153fb5bf6d
https://doi.org/10.1016/0042-6822(81)90021-0
https://doi.org/10.1016/0042-6822(81)90021-0
Autor:
Robert E. Shope, Robert B. Tesh, Charles H. Calisher, Frederick A. Murphy, Walter Brandt, Michael E. Wiebe, Nick Karabatsos, Jordi Casals
Publikováno v:
Intervirology. 14:229-232
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6c806de8f2febd63f75c55469cba8d6f
https://doi.org/10.1159/000149190
https://doi.org/10.1159/000149190