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. https://biotechnology.report/Resources/Whitepapers/3db0d2ab-f0ef-4b73-8d03-c934ea404f7e_BioAnalytix White Paper 1.2--Advanced HDX-MS and Native-MS in Biologic Development Issued Jan '19.pdf
whitepaper
SHARESHARESHARE
ADVANCED HDX-MS AND NATIVE-MS APPROACHES FOR IMPROVED BIOLOGIC CANDIDATE SELECTION AND DE-RISKED CMC AND CLINICAL DEVELOPMENT PROGRAMS
Despite substantial efforts utilizing a diverse set of biologic evaluation and highthroughput 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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