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… Click to show full abstract
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. rFVIII product quality determined aggregation propensity under use‐relevant stress.
Keywords:
subvisible particles;
aggregates subvisible;
factor viii;
protein
Journal Title: Journal of Thrombosis and Haemostasis
Year Published: 2018
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Journal Title: Journal of Thrombosis and Haemostasis
Year Published: 2018
Link to full text (if available)
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recommendations!