Aggregation analysis of pharmaceutical human immunoglobulin preparations using size-exclusion chromatography and analytical ultracentrifugation sedimentation velocity

Quantitation of aggregate levels in a re

Quantitation of aggregate levels in a recombinant humanized monoclonal antibody formulation by size-exclusion chromatography, asymmetrical flow field flow fractionation, and sedimentation velocity

✍ John P. Gabrielson; Mark L. Brader; Allen H. Pekar; Kathrin B. Mathis; Gerhard W 📂 Article 📅 2007 🏛 John Wiley and Sons 🌐 English ⚖ 167 KB

Size-exclusion high-performance liquid chromatography (SE-HPLC, SEC) is the long-standing biopharmaceutical industry standard for quantitation of soluble protein aggregates. Recently, sedimentation velocity analytical ultracentrifugation (SV-AUC) has emerged as a possible orthogonal technique to SEC