A Platform Approach to Managing Developability and Manufacturability Assessments of Biotherapeutics

June 5, 2019

Presented at ASMS 2019, Atlanta, GA, USA

Biotherapeutic drug candidates are selected not only for their desired pharmacological profile, but also for a set of properties that aim to reduce overall R&D costs, timelines, and scale-up and manufacturing risks. The potential of mass spectrometry (MS) to replace many conventional assays and its ability to accurately identify and quantify underlying molecular attributes of drug candidates make it amenable to developability and manufacturability assessments. We present the Genedata Biopharma Platform, which integrates MS data from any instrument or assay type and enables leverage of all data associated with a drug candidate captured across the entire R&D process. This best-in-class data curation ultimately allows transparent decision making and the implementation of artificial intelligence to predict developability and manufacturability.



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