pH and excipient profiles during formulation of highly concentrated biotherapeutics using bufferless media

Several models have been developed to describe the shifts in pH and excipient concentrations seen during diafiltration of monoclonal antibody (mAb) products accounting for both Donnan equilibrium and electroneutrality constraints. However, these models have assumed that the mAb charge is either cons...

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Veröffentlicht in:	Biotechnology and bioengineering 2020-11, Vol.117 (11), p.3390-3399
Hauptverfasser:	Jabra, Mario G., Tao, Yinying, Moomaw, John F., Yu, Zhao, Hotovec, Brian J., Geng, Steven B., Zydney, Andrew L.
Format:	Artikel
Sprache:	eng
Schlagworte:	Amino acid sequence Amino acids Antibodies, Monoclonal - analysis Antibodies, Monoclonal - metabolism antibody bufferless media Buffers Cell Culture Techniques - methods Constraint modelling Culture Media - chemistry Culture Media - metabolism diafiltration Electrostatic properties Excipients formulation Fusion protein Hydrogen Hydrogen-Ion Concentration Ionic strength Isoelectric points Mass balance Monoclonal antibodies Osmolar Concentration pH effects Proteins Protonation Static Electricity ultrafiltration Ultrafiltration - methods
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