Zobrazeno 1 - 5
of 5
pro vyhledávání: '"Dave Kolwyck"'
Publikováno v:
Biotechnology Progress.
Publikováno v:
Current Opinion in Chemical Engineering. 22:236-243
The current paradigm for raw material control in the biopharmaceutical industry remains a combination of compendial tests, function-based test and engineering controls. Moreover, ad hoc scale-down process studies remain the de facto approach to under
Autor:
Phil de Vilmorin, Rashmi Menon, Yutong Jin, Erin Laskowich, Linda Yi, Lisa Bareford, Bernice Yeung, Dave Kolwyck, Haiyan Liu
Publikováno v:
Journal of pharmaceutical sciences. 111(2)
A liquid chromatography-mass spectrometry (LC-MS) method was developed to provide a fingerprint of polysorbate 80 (PS80) subspecies that enables identification of PS80 degradation pathway. The developed method demonstrates unique monoester peak profi
Publikováno v:
Journal of pharmaceutical sciences. 110(4)
Growth of mammalian cells in the production of biotherapeutics often require the benefits of chemically defined media (CDM). Storage, handling and stability advantages of CDM powders govern the preponderance of their use across the industry. Physico-
Publikováno v:
PDA journal of pharmaceutical science and technology. 73(4)
A fast, reproducible, non-destructive method to confirm raw material identification in real-time upon material receipt within a warehouse environment is desired. Current practices in pharmaceutical manufacturing often employ compendia methods for raw