Biopharmaceuticals, unlike chemically synthesized small-molecule drugs, are marginally stable, with most of them requiring 3D structures to retain their activity and/or potency. This implies challenges to formulate these molecules for a shelf life >2 yrs and also to minimize the cost of goods for manufacturing. Patient compliance has become a key consideration in the design and development of suitable dosage forms in the modernized world. Thus, here we describe different classes of biological therapeutics, with an emphasis on molecular properties, formulation challenges, and development strategies. We also present statistics on the different classes of approved biologic drugs and dosage forms.

中文翻译：

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胃肠外生物药物制剂开发中的关键考虑因素。

与化学合成的小分子药物不同，生物药物的稳定性较差，其中大多数需要 3D 结构来保持其活性和/或效力。这意味着配制这些分子的保质期 > 2 年以及将制造商品的成本降至最低的挑战。在现代世界中，患者依从性已成为设计和开发合适剂型的关键考虑因素。因此，我们在这里描述了不同类别的生物疗法，重点是分子特性、配方挑战和开发策略。我们还提供了不同类别的获批生物药物和剂型的统计数据。