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September 12, 2025The AAPS JournalOpen Access

Insights from a Survey of Drug Formulation Experts: Challenges and Preferences in High-Concentration Subcutaneous Biologic Drug Development

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Authors

TLTerri A. LevineAKAmit KunduMHMichael J. Hageman

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Overview

Survey reveals formulation issues in high-concentration biologic drugs for subcutaneous delivery, highlighting viscosity and solubility challenges.

Key Points

  • Most experts identified solubility issues (75%) as a major challenge when developing high-concentration biologic drugs.
  • Seventy-two percent of respondents noted viscosity-related challenges as significant in transitioning biologic formulations.
  • About 69% of experts reported delays in clinical trials due to formulation difficulties, with an average delay of 11.3 months.
  • Feedback indicated that smaller concentration adjustments could lower risks and expenses in developing subcutaneous formulations.

Cite This Study

Levine et al. (2025) studied this question.

synapsesocial.com/papers/68d44a3731b076d99fa53622https://doi.org/10.1208/s12248-025-01132-8
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