High-concentration biologic formulations: challenges, strategies, and emerging technologies for subcutaneous delivery
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J Ma
European Journal of Pharmaceutics and …, 2026
Elsevier
The growing demand for subcutaneous (SC) self-administration of biotherapeutics, driven by the rising prevalence of chronic diseases and healthcare cost-containment pressures, has accelerated the development of high-concentration formulations (HCFs). However, protein concentrations exceeding 100 mg/mL introduce significant challenges, including solubility limitations, high viscosity, aggregation propensity, injectability constraints, and manufacturing complexities. This review systematically examines the primary obstacles in …
