Zobrazeno 1 - 3
of 3
pro vyhledávání: '"Annika Kleinjans"'
Autor:
Robert Puskeiler, Brian D. Kelley, Annika Kleinjans, Steven J. Meier, Rick St. John, Christian Hakemeyer, Fred Lim, Nathan McKnight, Melody Trexler-Schmidt, Christine Wurth, Frank Zettl
Publikováno v:
Biologicals. 44:306-318
Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the
Therapeutic antibodies have been manufactured since the advent of intravenous immunoglobulin in the 1950s. Rituxan was the first recombinant monoclonal antibody approved for therapeutic use by the U.S. Food and Drug Administration (FDA) in 1997. Now,
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::26ca106817d0797a51310a1fbc5e1829
https://doi.org/10.1016/b978-0-08-100623-8.00051-7
https://doi.org/10.1016/b978-0-08-100623-8.00051-7
Autor:
John W. Armando, E. Morrey Atkinson, Peter Bernhardt, Torbjörn S. Blank, Yvonne A. Brady, Eggert Brekkan, Andrea Buchacher, Karolina Busson, Maire H. Caparon, Enrique N. Carredano, Jeffrey R. Carter, Andreas Castan, Shuang Chen, Kenneth P. Clapp, Scott A. Cook, John T. Cundy, John M. Curling, Åke Danielsson, Kjell O. Eriksson, Alain Fairbank, Suzanne S. Farid, Simon Fischer, Kine A.-K. Frej, Parrish M. Galliher, Klaus Gebauer, Glen S. Giese, Alan Gilbert, Anna Grönberg, Albrecht Gröner, Robert S. Gronke, Martin Hall, Kim R. Hejnaes, Rachel S. Hendricks, Rolf A. Hjorth, Geoff Hodge, Matt H. Hutchinson, Günter Jagschies, Michael J. Jenkins, Mikael I. Johansson, John Joseph, Oliver Kaltenbrunner, Gautam Kapoor, Tomas M. Karlsson, Brian D. Kelley, Annika Kleinjans, Jashwant Kumar, Karol M. Łącki, Philip Lester, Jakob Liderfelt, Xin Xin Lin, Eva K. Lindskog, Mats Lundgren, Ratish Mangalath-Illam, Trevor J. Marshall, Joseph P. Martin, Krunal K. Mehta, Brian Montgomery, Daniel Nelson, Roger Nordberg, Dana A. Olson, Martin Östling, John P. Pieracci, David J. Pollard, Alain Pralong, Hari Pujar, Joost P. Quaadgras, Tom C. Ransohoff, Anurag S. Rathore, Craig Robinson, Jonathan Royce, Michael A. Rubacha, Henrik Sandegren, Andreas Schaubmar, Patrick Schulz, Sumit K. Singh, Stephen E. Sobacke, Sriram Srinivasan, Matthew J. Stork, Bruce S. Tangarone, Jorg Thommes, Matthew J. Traylor, Johan Tschöp, James M. Van Alstine, Johnson Varghese, Ganesh Vedantham, Thomas von Hirschheydt, William B. Wellborn, Till Wenger, Susanne Westin, David G. Westman, Matthew Westoby, William G. Whitford, Ambrose J. Williams, John M. Woodgate
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::7ab37a02755962071e60b3fe89a67442
https://doi.org/10.1016/b978-0-08-100623-8.09990-4
https://doi.org/10.1016/b978-0-08-100623-8.09990-4