Zobrazeno 1 - 4
of 4
pro vyhledávání: '"Flora J, Keumurian"'
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:
Paul W. Barone, Flora J. Keumurian, Caleb Neufeld, Andrea Koenigsberg, Robert Kiss, James Leung, Michael Wiebe, Rima Ait-Belkacem, Chakameh Azimpour Tabrizi, Cristina Barbirato, Pascale Beurdeley, Audrey Brussel, Jean-Pol Cassart, Colette Cote, Noémie Deneyer, Veera Dheenadhayalan, Leyla Diaz, Angela Geiselhoeringer, Maria M. Gilleece, Jakob Goldmann, Danielle Hickman, Angela Holden, Björn Keiner, Martina Kopp, Thomas R. Kreil, Christophe Lambert, Carine Logvinoff, Brandye Michaels, Jens Modrof, Brian Mullan, Jürgen Mullberg, Marie Murphy, Sean O'Donnell, José Peña, Michael Ruffing, Horst Ruppach, Nasrin Salehi, Shahjahan Shaid, Lindsey Silva, Richard Snyder, Mélancolie Spedito-Jovial, Olivier Vandeputte, Bernice Westrek, Bin Yang, Ping Yang, Stacy L. Springs
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization.
The Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) collected historical data from 20 biopharmaceutical industry members on their experience with the in vivo adventitious virus test, the in vitro virus test, and the use of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::18fdade44cfe97b4941436ee939b7239
https://pubmed.ncbi.nlm.nih.gov/36621353
https://pubmed.ncbi.nlm.nih.gov/36621353
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
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