Critical considerations in the formulation development of parenteral biologic drugs

• Published in: Drug discovery today 2020-03, Vol.25 (3), p.574-581
• Main Authors: Muralidhara, Bilikallahalli K., Wong, Marcus
• Format: Article
• Language: English
• ISSN: 1359-6446; 1878-5832
• DOI: 10.1016/j.drudis.2019.12.011

•Biologic drugs, in general, provide exceptional target specificity and less off-target effects compared to small molecule therapies.•Development and manufacturing of biologics is challenging and expensive and they invariably need cold-chain for distribution.•This article highlights different biologic modalities and critical considerations in developing them into patient friendly dosage forms for parenteral applications.•Cost of biologic therapies would substantially decrease in the coming decade as manufacturing technologies evolve to include artificial intelligence and continuous manufacturing. 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.