Method Migration Of Size-Exclusion And Ion- Exchange Methods For Monoclonal Antibody Analysis From HPLC To The Arc Premier System

By Brooke M. Koshel, David Dao, Robert E. Birdsall, Ying Qing Yu

Transferring methods between internal laboratories and external contract organizations is a key part of analytical development of biopharmaceuticals. The Arc Premier System was introduced as a modern UHPLC that can also support more routine assays traditionally run on HPLC platforms. Size exclusion and ion-exchange chromatography methods, two assays commonly used in quality control, showed reproducible results when migrating methods from an Alliance HPLC System. Differences in retention time and peak area percent were negligible between the two platforms, instilling confidence that the legacy method could be replicated successfully on the Arc Premier System.

As more modern LC platforms are incorporated into the laboratory, these new systems must demonstrate that they can produce comparable results to existing technologies. This work demonstrates that legacy SEC and IEX methods could be migrated from an Alliance HPLC System to an Arc Premier System with negligible differences in retention time and peak area percent. Discover how combining the Arc Premier System with modern UHPLC columns could make data more accurately interpreted through greater efficiency, selectivity, and enhanced resolution.