The impact of perceived volume limits on subcutaneous biologic drug development: an industry survey

As multiple large-volume subcutaneous (SC) biologics enter trials or gain approval, understanding how administration volume impacts biologic development is critical. While patients often prefer SC over intravenous administration, large-volume SC delivery adoption is hindered by the belief that SC delivery must be ≤3 mL without a permeation enhancer (PE). A 21-item online survey was conducted among professionals working in research and development; chemistry, manufacturing, and controls (CMC); portfolio strategy, new product planning; and combination products. Questions explored perceptions of SC administration volume limits, biologic deprioritization and abandonment, large-volume delivery considerations, and organizational approaches to revisiting deprioritized candidates. Eighty-eight participants completed the survey; 90.9% reported direct involvement in at least one project in which a biologic had been deprioritized or abandoned due to challenges achieving an SC volume of ≤3 mL. Respondents estimated that a weighted mean of 32.4% of relevant biologics had been abandoned and 28.9% had been deprioritized because of such challenges. Frequently selected reasons included limited experience with large-volume formulations or devices (29.5%), patient and/or healthcare provider preference (19.3%), and development costs or timelines (17.0%). Overall, 33.0% of respondents selected ≤3 mL as the maximum volume for SC infusion over several minutes without a PE. These findings indicate that perceived SC volume constraints may influence development decisions and highlight the importance of differentiating between device-related and physiological limits on SC administration volume. This study demonstrates that misconceptions about SC injection volume limits may lead to deprioritization or abandonment of viable assets during biologic development.