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pro vyhledávání: '"Björn-Hendrik Peters"'
Publikováno v:
Journal of pharmaceutical sciences. 111(9)
Polysorbate is a key excipient included in formulations of therapeutic proteins to help prevent aggregation and surface adsorption. The stability of both polysorbate and therapeutic proteins can be compromised by oxidative degradation. In general, po
Autor:
Björn‐Hendrik Peters, James Bautista, Thomas R. Slaney, Hongyue Guo, Richard Y.‐C. Huang, Mary E. Krause, Ming Zeng, Julie Cheng, Zhi Chen
Publikováno v:
Electrophoresis6 References. 43(9-10)
Antibody-based therapeutic proteins have highly complex molecular structures. The final therapeutic protein product may contain a wide range of charge variants. Accurate analysis of this charge variant composition is critical to determine manufacturi
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Autor:
C. Russell Middaugh, Christian Schöneich, Yangjie Wei, M. Laird Forrest, Björn-Hendrik Peters, Ninad Varkhede
Publikováno v:
J Pharm Sci
Oxidation of therapeutic proteins (TPs) can lead to changes in their pharmacokinetics, biological activity and immunogenicity. Metal impurities such as iron are known to increase oxidation of TPs, but nanoparticulate metals have unique physical and c
Autor:
Jimi Rantanen, Ferdinand Molnár, Jarkko Ketolainen, Lotte Staels, Vesa-Pekka Lehto, Björn-Hendrik Peters, Thomas De Beer
Publikováno v:
European Journal of Pharmaceutical Sciences. 95:72-81
Microscale freeze-drying makes rapid process cycles possible for early-stage formulation development. To investigate the effects of equipment scale and cooling rate on the solid state properties and the protein's secondary structure of a sample, thre
Autor:
Christian Schöneich, Björn-Hendrik Peters, Reza Esfandiary, Nicholas R. Larson, C. Russell Middaugh, Yangjie Wei, Suzanne Hudak, Cavan Kalonia, Sureshkumar Choudhary, Indira Prajapati
Publikováno v:
Journal of pharmaceutical sciences. 109(1)
Light exposure of a monoclonal antibody formulation containing polysorbate 80 (PS80) leads to cis/trans isomerization of monounsaturated and polyunsaturated fatty acids. This cis/trans isomerization was monitored by positive electrospray ionization m
Publikováno v:
Journal of Pharmaceutical Sciences. 104:3710-3721
Microscale (MS) freeze-drying offers rapid process cycles for early-stage formulation development. The effects of the MS approach on the secondary structures of two model proteins, lysozyme and catalase, were compared with pilot-scale (PS) vial freez
Autor:
Niklas Sandler, Elisabeth Peeters, Jukka Rantanen, Jarkko Ketolainen, Henrik Ehlers, Henrika Wickström, Kaisa Naelapää, Jean Paul Remon, Jurgen Vercruysse, Margot Fonteyne, Chris Vervaet, Thomas De Beer, Björn-Hendrik Peters
Publikováno v:
European Journal of Pharmaceutics and Biopharmaceutics. 87:252-263
Continuous manufacturing gains more and more interest within the pharmaceutical industry. The International Conference of Harmonisation (ICH) states in its Q8 'Pharmaceutical Development' guideline that the manufacturer of pharmaceuticals should have
Publikováno v:
European Journal of Pharmaceutics and Biopharmaceutics. 87:347-356
Downscaled freeze-drying was demonstrated to be a valuable alternative for formulation development and optimization. Although the pore structure is known to exert a major influence on the freeze-drying cycle, little is known about the ones of microsc