Method Development for Size-Exclusion Chromatography of Monoclonal Antibodies and Higher Order Aggregates
نویسنده
چکیده
in t ro du C t io n Since the early introduction of biologic based therapeutics, the presence of protein aggregates can compromise safety and efficacy.1 Given these factors, protein aggregates are typically monitored throughout the production of a biotherapeutic. While a variety of analytical techniques have been used to analyze soluble aggregates, the dominant technique continues to be size-exclusion chromatography (SEC).2
منابع مشابه
Development and partial validation of a SEC method for high-resolution separation and quantifi cation of monoclonal antibodies
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