USP-Compliant Analysis of Antibody Drugs Using Size-Exclusion Chromatography (SEC)


User Benefits

- The United States Pharmacopeia (USP)-compliant system compatibility test for antibody drugs can be performed with good repeatability. - The corrosion-resistant Nexera lite inert ensures stable data collection even when employing mobile phases with high salt concentration.


Proteins easily aggregate due to variances in temperature, pH, and concentration during the manufacturing process and storage. Since aggregation of protein products such as monoclonal antibodies (mAbs) may affect safety and efficacy, the degree of aggregation of the products is confirmed by dedicated analytical procedures (1). Size exclusion chromatography (SEC) is available as a method to confirm aggregation, and USP-NF 2022, Issue 2, General chapter <129> describes a procedure to analyze impurities in monoclonal antibodies using SEC (2). Since this method employs high concentration of salt in the eluent, there are some concerns about instrument deterioration due to precipitation and corrosion. This article introduces USP-complied SEC analysis of monoclonal IgG antibodies using Nexera lite inert, high-performance liquid chromatograph (HPLC), which is more durable against salt and acid than ordinary HPLC using stainless steel for wetted parts.

May 14, 2024 GMT

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