Schott Pharma, a pioneer in drug containment solutions and delivery systems, and Nemera, a world-leading provider of drug delivery device solutions and combination product services, have introduced the industry’s first passive safety system featuring a 5.5 l prefillable glass syringe. The solution addresses growing demand for large-volume drug delivery, driven by novel biologics, the shift from intravenous to subcutaneous administration, and the increasing adoption of homecare.
Together, these trends are accelerating the need for integrated delivery systems that enable safe, reliable, and user-friendly self-administration. For pharmaceutical companies, the solution helps reduce development complexity through a pre-aligned delivery platform. The system will be on display for the first time at CPHI Milan, 6-8 October (hall 11, booth 11A25) as well as at PDA Palm Springs, October 6-7 (booth 822), and is already available for technical assessment, compatibility studies, and development programs.
“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,” said Marc Hämel, CEO of Nemera.
“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,” said Christian Mias, CEO of Schott Pharma.
An integrated system for large-volume therapies
Safe’n’Sound 5.5 ml is the first passive safety system specifically engineered for large-volume subcutaneous injections using a prefillable glass syringe.
Building on Schott Pharma’s syriQ BioPure 5.5 ml syringe platform, Nemera developed the integrated system in close collaboration with Schott Pharma to ensure compatibility by design rather than through the adaptation of an existing safety device for a large-volume format.
The solution brings together Schott Pharma’s expertise in large-volume primary packaging with Nemera’s capabilities in drug delivery and patient-centered device design. It is particularly suited for therapies requiring higher injection volumes, including treatments for autoimmune, neurological, cardiovascular, and oncological conditions.
As Schott Pharma’s first large-volume staked-needle prefillable glass syringe, syriQ BioPure® 5.5 ml extends the company’s established syriQ BioPure platform into the growing large-volume drug delivery segment. Specifically designed for sensitive biologics, the syringe combines high-quality drug containment with broad compatibility across delivery systems. Its advanced manufacturing process achieves ultra-low tungsten residuals, reducing drug-container interactions, and supporting the safe and reliable administration of high value therapies.
Designed for safe and practical self-injection
The Safe’n’Sound passive safety system was developed using a user-centered design approach and validated through dedicated human factors studies conducted on behalf of both companies. These studies involved both device-naïve and experienced users with varying levels of hand strength and dexterity, including individuals with hand weakness or limited dexterity, to reflect a broad range of real-world users.
Across multiple syringe configurations, needle options, and viscosity levels, all participants successfully administered the full dose and correctly activated the safety system, demonstrating excellent usability and ease of use.
In parallel, extensive technical compatibility and performance testing were conducted on the integrated solution. This verification included syringe-device compatibility, injection performance, safety-system activation, and other critical functional parameters. The results confirmed reliable interaction between the syringe and device, as well as robust performance across different use scenarios.
Together, the human factors validation and technical verification demonstrate that the Safe’n’Sound system combined with Schott Pharma’s syriQ BioPure syringe platform provides a reliable and user-friendly solution for self-administration. By combining proven usability with verified technical performance, the integrated system supports safe, convenient, and effective at-home treatment.
Reducing complexity and accelerating development
Beyond safety and usability, the integrated system supports faster development timelines for pharmaceutical companies. Its pre-aligned compatibility is supported by structured design verification, human factors data, and regulatory documentation, helping to reduce development risks and avoid late-stage integration challenges.
This streamlined approach enables smoother progression from development to clinical and commercial readiness, offering a clear advantage in the rapidly evolving landscape of large-volume biologics and advanced therapies.
The collaboration between Schott Pharma and Nemera continues to expand, with ongoing compatibility testing on additional formats and configurations, extending the platform’s applicability across a broader range of therapies.
