During biotherapeutic manufacturing, process-related impurities derived from the host organism can contaminate drug products. These contaminants may significantly affect drug efficacy and sometimes cause immunogenicity, making their removal highly important to ensure drug safety and purity. Guillaume Tremintin et al. at Bruker Daltonics discuss why there is an ever-increasing requirement for analytical methods with rigorous process-related impurity testing, to monitor these contaminants during manufacture and prior to product release.
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