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of 3
pro vyhledávání: '"Bernice Westrek"'
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
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