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High-Dose Subcutaneous Administration of Biologics: Overcoming Barriers Through Formulation and Device Innovation.
Tarik A Khan1, Deep Bhattacharya2, Twinkle R Christian3
1Pharma Technical Development, Hoffmann-La Roche Ltd, Basel, Switzerland.
Advanced Drug Delivery Reviews
|May 12, 2026
Summary
The shift to subcutaneous (SC) biologic delivery requires new solutions like ultra-high concentration biologic (UHCB) suspensions and large-volume SC (LVSC) injections. Overcoming manufacturing and regulatory challenges is key to patient-centric high-dose SC therapies.
Area of Science:
- Biopharmaceutical development
- Drug delivery systems
- Patient-centric medicine
Background:
- Biologic therapies are shifting from intravenous (IV) to subcutaneous (SC) administration for improved patient convenience and cost-effectiveness.
- This transition necessitates innovative SC drug delivery solutions to manage higher doses.
- Current trends focus on higher concentration formulations and large-volume SC administration.
Purpose of the Study:
- To explore emerging strategies for patient-centric subcutaneous biologic administration.
- To identify innovative formulation and delivery approaches for high-dose SC biologics.
- To discuss the challenges and future directions in translating these technologies.
Main Methods:
- Investigating ultra-high concentration biologic (UHCB) suspensions (≥250 g/L) using microparticle entrapment techniques.
- Examining large-volume SC (LVSC) administration strategies involving hyaluronidase co-formulation and specialized devices (OBIs, HVAI).
- Analyzing the hurdles in commercial translation, including aseptic manufacturing, analytical controls, device compatibility, and regulatory pathways.
Main Results:
- UHCB suspensions are being developed using methods like spray drying and electrospraying, resulting in shear-thinning injectable solutions.
- LVSC delivery is facilitated by co-formulation with hyaluronidase and advanced administration devices.
- Preclinical data show promise, but significant challenges remain for commercialization.
Conclusions:
- Successful development of patient-centric high-dose SC biologics requires overcoming manufacturing, analytical, device, and regulatory obstacles.
- Collaborative efforts between industry and regulatory bodies are crucial for streamlining development.
- These advancements aim to enhance patient convenience and treatment flexibility.
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