Explore & develop bioanalytical methodologies to monitor the physical stability of co-formulated drug product

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Coformulation of therapeutics is an emerging strategy. Combination drugs offer the synergistic benefits of 6Cs (Combination, Compliance, Concordance, Convenience, Carriage and Cure-all). Despite these benefits, the pharmaceutical sector faces 1) clinical and regulatory challenges, and (2) drug product development and analytical challenges to bring these new combination biological drug products to market. Identification of single solution condition to support multiple active components is observed to be challenging; limitations with current bioanalytical methodologies to identify any non-native interactions, and to monitor heterogeneous aggregates, could be major obstacles when attempting to coformulate two or multiple biologics.