Aptar Pharma and Stevanato Group are collaborating to help pharmaceutical and biotechnology companies evaluate pre-filled syringe systems earlier in drug development, combining glass syringe platforms with elastomeric components to generate data on assembled-system performance. The initiative targets the growing challenges associated with packaging sensitive biologics, high-concentration formulations and other injectable medicines. As these products become more complex, manufacturers need to understand how container and closure components interact to ensure the selected delivery system performs as intended.

The collaboration builds on Aptar Pharma’s integrated system-level framework, introduced in July 2026, and brings together the companies’ respective expertise in elastomeric components, prefillable syringes and primary drug containment. Joint testing covers Stevanato Group’s EZ-fill Nexa and Alba glass syringe platforms, paired with Aptar Pharma’s PremiumCoat and uncoated plungers, as well as rigid needle shield options for standard syringe and autoinjector configurations. The companies are evaluating the components as complete systems to provide development teams with earlier insight into potential compatibility and performance issues.

Initial activities focus on 1 mL long and 2.25 mL syringe formats. Testing includes rigid needle shield removal force, plunger break-loose and extrusion forces, container closure integrity and plunger seal integrity across selected configurations and viscosity profiles. The teams are also examining how design variables, including needle geometry, can affect the forces required to initiate and maintain injection.

The resulting data packages are intended to support technical feasibility assessments, risk evaluation and packaging selection. The work is designed to help customers address applicable requirements under United States Pharmacopeia (USP) General Chapter 382, which covers elastomeric component functionality in injectable pharmaceutical packaging and delivery systems. Regulatory support services are also available to assist manufacturers throughout the product lifecycle.

“Through this joint work, we aim to provide pharmaceutical teams with earlier insight into component interactions and system performance to support informed development decisions,” says Audrey Chardonnet, vice president of global market development for injectables at Aptar Pharma.

Riccardo Marcon, senior vice president of sales and marketing for drug containment solutions at Stevanato Group, says the combined expertise could give customers greater confidence in assessing packaging configurations and identifying potential technical risks before advancing development.

By generating performance data at the assembled-system level, the companies aim to help drug developers narrow packaging options sooner and make better-informed decisions as programs move from initial feasibility studies toward scale-up and commercialization. However, pharmaceutical manufacturers remain responsible for demonstrating that their final packaging and delivery systems are suitable for their products and meet applicable regulatory requirements.

Learn more at http://www.aptar.com.