Zobrazeno 1 - 10
of 39
pro vyhledávání: '"BRIAN D. KELLEY"'
Publikováno v:
Biotechnology Progress. 37
Few monoclonal antibodies are currently approved for treating infectious diseases, but multiple products are in development against a broad range of infectious diseases, including Ebola, influenza, hepatitis B, HIV, dengue, and COVID-19. The maturity
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
Autor:
Christopher Williams, Ti Zhao, Benjamin Tran, Brian D. Kelley, Paul J. Mcdonald, Marc Wong, Philip Lester
Publikováno v:
Journal of Chromatography A. 1433:66-74
Cation-exchange chromatography is widely used in the purification of therapeutic antibodies, wherein parameters such as elution pH and counterion concentration require optimization for individual antibodies across different chromatography resins. Wit
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
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:
Brian D. Kelley
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization. 44(5)
Autor:
Lynne A. Krummen, Brian D. Kelley, Niklas Engler, Raquel Iverson, Gerald Gellermann, Ron Taticek, Christof Finkler, Reed J. Harris, Lynn A. Gennaro, Mary E.M. Cromwell, J. Felix Kepert, Nathan McKnight, Paul Motchnik, Volker Schnaible
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization. 44(5)
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
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization. 44(5)
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
Publikováno v:
Biotechnology Progress. 27:140-152
Formulation of protein biopharmaceuticals as highly concentrated liquids can improve the drug substance storage and supply chain, improve the target product profile, and allow greater flexibility in dosing methods. The Donnan effect can cause a large