As biopharma accelerates the transition from hospital-based intravenous (IV) infusions to at-home subcutaneous administration, containment and delivery specialists SCHOTT Pharma and Nemera have partnered to launch the industry’s first passive safety system integrated with a 5.5 mL prefillable glass syringe.

“As more therapies move closer to the patient’s home, the need for safe and reliable large-volume self-injection continues to grow. This collaboration with SCHOTT Pharma marks an important step forward, bringing together complementary expertise to deliver the first integrated safety system specifically designed for large-volume self-injection and support a better patient experience,” says Marc Hämel, CEO of Nemera.

The co-developed platform pairs Nemera’s Safe’n’Sound® passive safety device with SCHOTT Pharma’s syriQ BioPure® 5.5 mL glass syringe. Rather than retrofitting a legacy safety device to a larger barrel, the partners engineered the system from the ground up to address the technical and ergonomic challenges of high-volume, high-viscosity biologic injections. Viscous formulations and larger volume thresholds—often required for complex biologics in oncology, neurology, cardiovascular, and autoimmune indications—present distinct packaging and delivery hurdles.

“Built on our large-volume glass syringe platform and developed in close collaboration with Nemera, this integrated solution helps pharmaceutical companies reduce complexity, accelerate development, and bring innovative biologic therapies to patients faster,” says Christian Mias, CEO of SCHOTT Pharma

To preserve sensitive biologic molecules, SCHOTT Pharma’s syriQ BioPure® 5.5 mL prefillable syringe features ultra-low tungsten residual manufacturing, minimizing container-closure interactions that can lead to protein aggregation. As SCHOTT Pharma’s initial large-volume, staked-needle glass platform, it provides primary containment designed to interface smoothly with secondary delivery hardware. Complementing the glass primary container, Nemera’s Safe’n’Sound® passive safety platform automatically guards the needle post-injection, shielding patients and caregivers from accidental needle-sticks without requiring manual activation.

Delivering 5 mL or more via subcutaneous injection demands careful consideration of plunger force, administration duration, and user dexterity. To validate real-world usability, both companies conducted collaborative human factors studies across diverse user profiles, including device-naïve individuals and patients with impaired hand strength. Testing evaluated multiple fluid viscosities, needle gauges, and fill configurations, with all cohorts achieving complete dose delivery and successful safety device activation.

From a regulatory and drug development standpoint, pre-aligned primary and secondary packaging eliminates common late-stage interface failures. The integrated platform comes backed by technical verification data—covering mechanical compatibility, injection force profiles, and safety activation—alongside human factors protocols and regulatory documentation packages aimed at shortening timeline-to-clinic for combination products.

The combined 5.5 mL platform is currently available for drug product compatibility evaluations, technical testing, and clinical development programs. Both organizations confirmed that joint testing remains ongoing to extend the integrated safety architecture across additional syringe geometries and device configurations.

For more information, visit: www.nemera.net.