Assessing Performance and Method Transfer of Monoclonal Antibody and Peptide Bioseparation Methods Using a Novel Biocompatible UHPLC System

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Brooke M. Koshel, Ximo Zhang, Robert Birdsall, Corey Reed, Stephan Koza, Zhimin Li, and Paula Hong
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Many of the top-selling pharmaceuticals currently on the market and in the pipeline are biologics. Because biologics are more complex than small molecules, analytical methods for analysis and regulatory requirements tend to be less straightforward. To date, many of the methods used in development and quality control laboratories are HPLC-based. While this may be sufficient in some cases, there are noted advantages of updating legacy systems and methods with more modern instrumentation. Regulators also recognize and support the notion for improving process performance through lifecycle management in an effort to enhance product quality and patient safety.

The product lifecycle includes development and manufacturing activities as well as technology transfers. When adopting new technology, it is of critical importance that instrumentation be robust and easily deployed. In this work, a new-to-market biocompatible UHPLC platform will be used to demonstrate the benefits of laboratory modernization in support of lifecycle management. Ion exchange, size exclusion, and peptide mapping are among the methods used to demonstrate equivalency across HPLC, UHPLC, and UPLC platforms. By updating from an HPLC platform, better resolution, shorter run time, and greater peak capacity can be achieved. As analytical assays are transferred to various in-house laboratories and contract organizations, it is imperative that results are consistent among sites. Method transfer across multiple instrument platforms is also demonstrated and assessed using retention time and peak area percent. By modernizing laboratory instrumentation, legacy methods can be successfully reproduced or updated to take advantage of new column technologies and lower dispersive systems for various improvements in performance.

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