Waters Podcast # 2: Getting more specificity in host cell protein analysis using proteomics approaches

UPLC, QTof, HDMS, and more: A practical guide to the hottest techniques driving the future of biopharmaceutical science

As firms increasingly invest in biopharmaceutical development, there is a widespread need to educate scientists in new technologies and approaches in this rapidly evolving industry. For maximum effectiveness in drug development, the application of new techniques can save time and development costs. In this podcast series, we’ll provide you with a firm knowledge of the latest technological innovations in LC and LC/MS that have been designed to address and advance the very specific needs of the many applications areas in the biopharmaceutical laboratory.

Through a variety of topics highlighting our latest scientific work, this series will help you gain a better understanding of key bio-focused LC, MS, and software advancements. Learn how these solutions have been adopted by industry leaders around the world and how easy it is to implement the tools that deliver faster, better answers relating to the character and quality of your biopharmaceuticals.

In this episode, we will introduce the capabilities added by the analysis of residual Host Cell Proteins by LC/MS. Regulation guidelines for biotherapeutics ask organizations to monitor for HCPs as potential process-related impurities. HCPs can seriously impact a biotherapeutic's efficacy, can kill a promising candidate in development, or even worse can be a risk for immunogenicity. Current tests generally only look for specific HCPs, take weeks to develop, and may not provide enough quantitative information. More recent work with UPLC-MSE has shown that detailed information can be obtained in a shorter time period that corroborates other tests and adds to the information content. Mass spectrometry has also advanced to the stage where unknown HCPs can be identified at ppm levels. Quantification can be done simultaneously or potentially as a monitoring step with isotopically-labeled signature peptides. All of these capabilities provide more information on which an organization can act in the problematic areas of HCPs.