Method Transfer of RPLC Methods for Peptide Mapping Using a Novel Dual Flow Path Biocompatible UHPLC System

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Brooke M. Koshel, Robert Birdsall, Corey Reed, Stephan Koza, Zhimin Li, Paula Hong, and Ying Qing Yu
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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 dual flow path biocompatible UHPLC platform will be used to demonstrate the benefits of laboratory modernization in support of lifecycle management. An HPLC method for peptide mapping is scaled to demonstrate equivalency across HPLC, UHPLC, and UPLC platforms. By updating from an HPLC platform, better resolution, shorter run time, and narrower peak profiles 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. Intersystem reproducibility is shown among three systems and assessed using retention time and peak area percent RSD. Finally, an in-line mass detector will be used to confirm CDR peptides of a monoclonal antibody standard, which adds confidence to results within a biotherapeutic environment.

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