Zobrazeno 1 - 7
of 7
pro vyhledávání: '"Melody Trexler-Schmidt"'
Autor:
Edward Koepf, Sarah L Demmon, Marisa K. Joubert, Swapnil Bhargava, Phillip Smith, Philip Tsai, Nomalie Jaya, Doreen Ciolek, Melody Trexler-Schmidt, Jennifer Halley
Publikováno v:
Biologicals. 67:9-20
Identification of Critical Quality Attributes (CQAs) and subsequent characterization in process development studies are the key elements of quality by design (QbD) for biopharmaceutical products. Since the inception of ICH Q8R2, several articles have
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
Air sparging for prevention of antibody disulfide bond reduction in harvested CHO cell culture fluid
Autor:
Michael W. Laird, Melissa Mun, Melody Trexler-Schmidt, James Dvornicky, Yung-Hsiang Kao, Stefanie Khoo, Aline Do Minh
Publikováno v:
Biotechnology and Bioengineering. 112:734-742
During the scale-up of several Chinese Hamster Ovary (CHO) cell monoclonal antibody production processes, significant reduction of the antibody interchain disulfide bonds was observed. The reduction was correlated with excessive mechanical cell shear
Autor:
Min Zhang, Melody Trexler-Schmidt, Kurt Brorson, Daniel Coleman, Philip Lester, Bin Yang, Michael Lee, Lenore A. Norling, George Miesegaes, Qi Chen
Publikováno v:
Biotechnology and Bioengineering
Protein A chromatography is widely used as a capture step in monoclonal antibody (mAb) purification processes. Antibodies and Fc fusion proteins can be efficiently purified from the majority of other complex components in harvested cell culture fluid
Air sparging for prevention of antibody disulfide bond reduction in harvested CHO cell culture fluid
Autor:
Melissa, Mun, Stefanie, Khoo, Aline, Do Minh, James, Dvornicky, Melody, Trexler-Schmidt, Yung-Hsiang, Kao, Michael W, Laird
Publikováno v:
Biotechnology and bioengineering. 112(4)
During the scale-up of several Chinese Hamster Ovary (CHO) cell monoclonal antibody production processes, significant reduction of the antibody interchain disulfide bonds was observed. The reduction was correlated with excessive mechanical cell shear
Publikováno v:
Biotechnology and bioengineering. 107(4)
We recently observed a significant disulfide reduction problem during the scale-up of a manufacturing process for a therapeutic antibody using a CHO expression system. Under certain conditions, extensive reduction of inter-chain disulfide bonds of an
Identification and prevention of antibody disulfide bond reduction during cell culture manufacturing
Autor:
Melissa Mun, Sandy Sargis, Stefanie Sze-Khoo, Michael W. Laird, Jason Chiu, Yung-Hsiang Kao, Melody Trexler-Schmidt
Publikováno v:
Biotechnology and bioengineering. 106(3)
In the biopharmaceutical industry, therapeutic monoclonal antibodies are primarily produced in mammalian cell culture systems. During the scale-up of a monoclonal antibody production process, we observed excessive mechanical cell shear as well as sig