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

治疗剂的共制剂是一种新兴的策略。联合用药提供了6C（组合，依从性，一致性，方便性，携带和治愈所有）的协同效益。尽管有这些好处，制药行业面临着1）临床和监管挑战，以及（2）将这些新的组合生物制剂推向市场的制剂开发和分析挑战。观察到支持多种活性组分的单一溶液条件的鉴定是具有挑战性的;当前生物分析方法在鉴定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尝试共同配制两种或多种生物制剂时的主要障碍。

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.