Ultrahigh‑Concentration Subcutaneous Delivery of Biotherapeutics Enabled by a High‑Tg Excipient

Anna Putnam – Vice President, Head of Surf Bio Business Unit, Halozyme Therapeutics; Charles Theuer – Senior Vice President, Chief Medical Officer, Halozyme Therapeutics; David Kang – Director, Drug Delivery, Halozyme Therapeutics; Carolyn Jons – Principal Scientist 1, Halozyme Therapeutics; Marie Printz – Executive Director, Bioanalytical and Nonclinical Sciences, Halozyme Therapeutics; Ryan Nolan – Senior Director, Nonclinical Sciences & Clinical Pharmacology, Halozyme Therapeutics; Mike Bledsoe – Director, Analytical Development, Halozyme Therapeutics; Doug Hecker – Vice President, API & Drug Product Manufacturing, Halozyme Therapeutics; Lexie Niroomand – Senior Research Associate 1, Halozyme Therapeutics

Introduction: High‑dose protein therapeutics are central to modern drug pipelines, yet many remain limited to intravenous administration. While subcutaneous delivery is more patient‑centric, it is constrained by protein instability at high concentration and aqueous viscosity that impairs injectability. We present a formulation platform, using a proprietary high glass‑transition temperature (Tg) excipient, that stabilizes proteins during spray‑drying and enables ultra-high‑concentration subcutaneous delivery of biotherapeutics such as monoclonal antibodies [1,2].