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

Area of Science:

• Biopharmaceutical development
• Drug formulation science
• Subcutaneous drug delivery

Background:

• Developing high-concentration subcutaneous (SC) biologic formulations from intravenous (IV) counterparts presents significant challenges.
• These challenges impact formulation volume, viscosity, and stability, affecting drug delivery and patient administration.

Purpose of the Study:

• To gather insights from drug formulation experts on the challenges and preferred approaches for transitioning IV biologic formulations to SC delivery.
• To understand expert perceptions regarding formulation volume and development strategies for high-concentration SC biologics.

Main Methods:

• An online survey was conducted with 100 biotechnology and pharmaceutical industry experts familiar with high-concentration (≥100 mg/mL) SC biologic formulations.
• Experts ranked seven approaches for IV to SC formulation transition, focusing on concentration changes, container modifications, and delivery systems.

Main Results:

• Increasing drug concentration for SC delivery was perceived as riskier, more time-consuming, and costlier than using on-body delivery systems (OBDS) with maintained concentrations.
• Key formulation challenges included solubility (75%), viscosity (72%), and aggregation (68%).
• Sixty-nine percent of respondents reported clinical trial or product launch delays due to high-concentration SC formulation issues, with a weighted mean delay of 11.3 months.

Conclusions:

• Minimizing concentration changes when transitioning IV biologics to SC formulations can reduce development risks, time, and costs.
• Further education is needed on developing low-concentration, large-volume SC formulations using advanced delivery systems like SC infusion pumps or OBDS.