Comparative analysis of marketed factor VIII products: recombinant products are not alike vis‐a‐vis soluble protein aggregates and subvisible particles

Essentials Aggregation is a critical quality attribute of protein therapeutics influencing immunogenicity. Aggregates and subvisible particles in 9 recombinant factor VIII (rFVIII) products were analyzed. Major differences in aggregate and particle concentrations were detected after reconstitution....

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Veröffentlicht in:	Journal of thrombosis and haemostasis 2018-06, Vol.16 (6), p.1176-1181
Hauptverfasser:	Anzengruber, J., Lubich, C., Prenninger, T., Gringeri, A., Scheiflinger, F., Reipert, B. M., Malisauskas, M.
Format:	Artikel
Sprache:	eng
Schlagworte:	Chromatography Coagulation factors Comparative analysis factor VIII Factor VIII deficiency Flow cytometry Hemophilia hemophilia A High-performance liquid chromatography Immunogenicity Insulin Interferon Patients protein aggregates protein stability Proteins recombinant proteins Spas
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