Presented at PEGS, Boston, MA, USA
In the process of discovery and development of novel biologics as therapeutic agents the early assessment of their quality and developability is crucial. Therefore, more and more analytics methods are being applied on an increasing number of drug candidates in earlier stages of the biopharma R&D workflows. In parallel, data management systems are needed to help researchers keep track of the molecules, their samples, and their characteristics. The analytics parameters being tracked include not only biological data such as bioactivity, but also physicochemical data such as glycosylation, chemical liabilities (PTMs and other factors introducing heterogeneity into the molecule), aggregation, stability under different conditions (low pH, low and high temperature), solubility, serum compatibility, impurities, and many more. We present a biopharmaceutical therapeutic R&D workflow management platform that structures the vast amounts of analytics data that are generated during the R&D process. This system helps to keep track of the quality of the produced materials and directly facilitates developability assessments.