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

联合配方疗法是一种新兴的策略。联合用药提供6Cs(联合、依从性、协调性、便利性、携带性和治愈性)的协同效益。尽管有这些好处，制药部门仍面临1)临床和监管挑战，以及(2)将这些新的组合生物药物产品推向市场的药物产品开发和分析挑战。人们观察到，确定支持多个活性成分的单一溶液条件是具有挑战性的；当前生物分析方法在识别任何非天然相互作用和监测异质聚集体方面的局限性，可能是试图共同配制两种或多种生物制品时的主要障碍。

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.