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

• Published in: Journal of bioscience and bioengineering Vol. 115; no. 1; pp. 104 - 110
• Main Authors: Krayukhina, Elena, Uchiyama, Susumu, Nojima, Kiyoko, Okada, Yoshiaki, Hamaguchi, Isao, Fukui, Kiichi
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 01.01.2013; Elsevier
• Subjects: Analytical ultracentrifugation sedimentation velocity; Biological and medical sciences; Biotechnology; Chromatography; Chromatography, Gel; computer software; drug formulations; drugs; Freeze Drying; Fundamental and applied biological sciences. Psychology; Gaussian skim; gel chromatography; Humans; Immunoglobulin; immunoglobulins; Immunoglobulins - analysis; Immunoglobulins - chemistry; Immunoglobulins - isolation & purification; integration; Japan; methods; pharmaceutical industry; quantitative analysis; Reproducibility of Results; Size-exclusion chromatography; Software; Ultracentrifugation; Vertical drop method; Japan; Analytical ultracentrifugation sedimentation velocity; Immunoglobulin; Size-exclusion chromatography; Gaussian skim; Vertical drop method; Aggregation; Human; Drug; Immunoglobulins; Method; Sedimentation; Chromatography

In the pharmaceutical industry, analysis of soluble aggregates in pharmaceutical formulations is most commonly performed using size-exclusion chromatography (SEC). However, owing to concerns that aggregates can be overlooked by SEC analysis, it has been suggested that its results should be confirmed...