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Biotherapeutics have become the hottest topic in pharmaceutical research over the past decade. With the increased interest in biotherapeutics, there has been a concomitant increase in new analytical methods for characterizing these large, complex molecules. This installment of “Column Watch” discusses advances in “bottom-up” analysis of monoclonal antibodies, while highlighting the role and importance column chemistry still plays in developing highly selective high-performance liquid chromatography (HPLC) methods for peptides.

Do you have questions about how to ensure data integrity? Then tune into this podcast series from LCGC. In this episode, hear from data integrity and quality systems expert Mark Newton about the shifting focus in data integrity, common problems and questions, and what you need to think about as you address data integrity in your company, or as you update software.

Do you have questions about how to ensure data integrity? Then tune into this podcast series from LCGC. In this episode, hear from data integrity and quality systems expert Mark Newton about dealing with data integrity issues arise in connection with sampling, sample preparation, aborted chromatographic runs, chromatographic integration, hybrid models, and more.

Do you have questions about how to ensure data integrity? Then tune into this podcast series from LCGC. In this episode, hear from data integrity and quality systems expert Mark Newton about the role of second-person review, the four Cs, training, oversight, and preparing for the future. 

Just as medical practitioners are able to discern worrying features from a variety of medical physics devices (electrocardiogram, electroencephalogram, ultrasound, for example), we need to develop the skill to identify worrying symptoms from our HPLC instrument output.

If you have a method or process that involves a number of different variables, multivariate optimization approaches can provide a faster route to optimum conditions and can lead to a more reliable outcome than using a one-factor-at-a-time approach. With a little study and practice, students and researchers can apply these optimization techniques, even if a complete understanding of the underlying statistical treatments is not immediately apparent.

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A surge in the development and commercialization of monoclonal antibody (mAb)-based ther-apeutics has driven the requirement for accurate and reproducible analytical methods for pro-tein characterization. Monoclonal antibodies are popular biologic drug candidates, but are sus-ceptible to a myriad of modifications during manufacture and complex degradation pathways during purification and storage, often leading to distinct charge variants that require character-ization and quantification. Ion‑exchange liquid chromatography (IEX) is a well-accepted and widely used technique to separate various mAb charge variant species for the sake of charac-terization and profiling. With the most recent advances in analytical technologies, IEX can be used to help ensure the selection of stable and efficacious mAb drug candidates, from discov-ery through manufacturing.