The impact of perceived volume limits on subcutaneous biologic drug development: an industry survey
Year: 2026
Type: article
Study design: Observational Study
Abstract: 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.
Source: Figshare
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W7225562262