Poster Presentations
- Day 1, May 11（Mon.） Poster (1008/09)
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1P-03 PDF
A Platform Approach to Managing Developability and Manufacturability Assessments of Biotherapeutics
Biotherapeutic drug candidates are selected for their desired pharmacological profile and a set of properties that aim to reduce overall R&D costs, timelines, and scale-up and manufacturing risks. Mass spectrometry (MS) methods can accurately identify and quantify underlying molecular attributes of drug candidates, making them 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—allowing transparent decision making and the implementation of artificial intelligence to predict developability and manufacturability.
In this example, purification batches of drug candidates were analyzed by LC-MS to measure their molecular mass. Protein sequences were automatically imported from the database. A total of 56 GB of raw data from 316 LC-MS experiments was directly collected, processed, and analyzed. Relevant chromatographic peaks were automatically detected and used to identify retention time ranges for signal deconvolution. Each sample was reported and compared with predefined criteria to provide a “traffic-light” classification. The fully integrated molecule, material, and analytical data management provided by the platform offers highly structured and interrogable data uniquely suited to advanced analytics and predictive modeling.