Peer-Reviewed White Paper

Advanced HDX-MS and Native-MS for Improved Biologic Candidate Selection and Development


Jennifer S. Chadwick, PhD
Kirtland Poss, MBA
Shiaw-Lin Wu, PhD


Despite substantial efforts utilizing a diverse set of biologic evaluation and high-throughput techniques to select candidates with the best chance of success in preclinical development, the vast majority of biologic drug molecules fail in clinical trials. With most biologic drugs, including gene therapies, failures are realized in late-stage development, after substantial investment has been made in a candidate. Here, we discuss the potential for improving identification of potentially successful biologic drugs and de-risking CMC and clinical designs earlier through strategic application of advanced mass spectrometry, and specifically, how detailed assessment of target engagement using HDX-MS and Native-MS analyses may provide understanding to guide biologic development decisions.

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