Breaking The Concentration Barrier: New Long-Term Stability And PK Data For Subcutaneous Nanotrastuzuma

Subcutaneous (SubQ) delivery is increasingly favored over intravenous infusion for biologics, offering greater patient convenience, a reduced administration burden, and lower healthcare costs. Developing high-dose SubQ biologics, however, remains constrained by the viscosity, stability, and injectability limits of conventional aqueous protein formulations—challenges that become especially acute for monoclonal antibodies, where therapeutic doses often require several hundred milligrams of protein.

In this webinar, Nanoform presents a novel ultra-high-concentration trastuzumab suspension enabled by nanoparticle engineering, achieving antibody loading of 440 mg/mL in a non-aqueous carrier system. The formulation demonstrated excellent stability over 12 months under both refrigerated and ambient storage, maintaining protein integrity, particle characteristics, suspension stability, and injectability from prefilled syringes. In preclinical studies in Göttingen minipigs, the ultra-high-concentration nanotrastuzumab delivered pharmacokinetic performance comparable to the commercially available Herceptin HYLECTA™, with good tolerability, while reducing injection volume by approximately 75%. Together, these findings illustrate how ultra-high-concentration biologic suspensions may overcome current formulation limitations and help enable the next generation of patient-centric, low-volume SubQ therapies.

Viewers will come away with an overview of Nanoform's large-molecule Nanoforming® technology platform for patient-centric dosage forms; an understanding of how its particle-engineering technology enables ultra-high-concentration monoclonal antibody formulations while addressing the key SubQ delivery challenges of stability, viscosity, and injection volume; and an assessment of new long-term stability and pharmacokinetic data for subcutaneous nanotrastuzumab and its potential to support patient-friendly administration of biologic therapies.