Aptar Pharma and Stevanato Group Collaborate to Advance Pre-Filled Syringe System Evaluation for Injectable Drug Development
Aptar Pharma, part of AptarGroup, and Stevanato Group have announced a collaboration designed to help biotechnology and pharmaceutical companies evaluate pre-filled syringe configurations earlier in the development of injectable medicines. The initiative combines the companies’ complementary expertise in elastomeric components, prefillable syringe systems and primary drug containment to provide system-level performance data for increasingly complex injectable therapies.
The collaboration focuses particularly on sensitive biologics and other injectable treatments, including formulations that present technical challenges because of their concentration, viscosity or compatibility requirements. As pharmaceutical companies develop more advanced biologic medicines and high-concentration formulations, the performance of packaging and delivery components becomes increasingly important. Evaluating individual components alone may not provide a complete understanding of how they will function together in an assembled drug delivery system.
Through this initiative, Aptar Pharma and Stevanato Group aim to give pharmaceutical development teams earlier access to technical information about assembled pre-filled syringe systems. The resulting data is intended to support feasibility assessments, inform packaging decisions and help identify potential technical challenges before projects advance into later development stages.
The joint work builds on Aptar Pharma’s integrated system-level framework, launched in July 2026, which emphasizes collaboration, integrated testing and performance data to support injectable drug development. By extending this approach through cooperation with Stevanato Group, Aptar Pharma is expanding the availability of system-level information across the injectable drug delivery value chain.
Combining Expertise in Syringe Systems and Elastomeric Components
The collaboration brings together Aptar Pharma’s expertise in elastomeric components with Stevanato Group’s capabilities in prefillable syringe systems, primary containment and system performance.
Aptar Pharma develops components and technologies that support drug delivery, dosing and protection. Its experience in elastomeric materials and injectable packaging components is relevant to the performance of syringe systems, where seals, plungers and needle protection elements must function reliably alongside the primary container.
Stevanato Group contributes expertise in glass syringe platforms and pharmaceutical containment solutions. Its prefillable syringe technologies are designed to support pharmaceutical manufacturers developing injectable drug products that require suitable packaging, dependable containment and compatibility with delivery devices.
The joint evaluation covers Stevanato Group’s EZ-fill® Nexa® and Alba® glass syringe platforms in combination with Aptar Pharma’s PremiumCoat® and uncoated plungers. The work also includes Aptar Pharma rigid needle shield options for standard syringe configurations and autoinjector applications.
Assessing these components together allows the companies to examine the performance of complete assemblies rather than considering each component in isolation. This approach can help reveal interactions between container and closure elements that may affect usability, sealing performance or the forces required to operate a syringe.
The evaluations use an approach designed to support pharmaceutical customers in meeting the requirements of United States Pharmacopeia General Chapter USP <382>, which addresses elastomeric component functionality in injectable pharmaceutical packaging and delivery systems.
The companies aim to provide development teams with a clearer understanding of potential packaging options and the technical considerations associated with each configuration. This information can help manufacturers make more informed decisions as they select components for specific drug formulations and delivery requirements.
Evaluation of Multiple Syringe Formats and Performance Parameters
Current activities cover two pre-filled syringe formats: 1 mL long and 2.25 mL. The evaluations examine system performance across selected configurations and viscosity profiles, generating data intended to support customers’ development and regulatory activities.
The assessment includes several important performance parameters:
- Rigid needle shield pull-off force: Evaluating the force needed to remove the needle shield can help characterize an important aspect of syringe handling and preparation for injection.
- Plunger break-loose force: Measuring the force required to initiate plunger movement provides information about the initial operating characteristics of the assembled syringe.
- Plunger extrusion force: Assessing the force required to move the plunger through the syringe helps characterize the system’s operating behavior during delivery.
- Container closure integrity: Evaluating the integrity of the assembled container closure system helps assess its ability to maintain the required containment of the drug product.
- Plunger seal integrity: Examining the performance of the plunger seal provides additional information about the interaction between the elastomeric component and the syringe barrel.
These parameters are relevant to pharmaceutical development because injectable systems must balance containment, functionality and compatibility with the intended formulation and administration method.
The forces involved in operating a syringe can vary depending on several factors, including formulation viscosity, component selection, syringe design and needle geometry. By examining selected configurations across different viscosity profiles, the companies seek to provide developers with information that can help narrow the range of technical options requiring further investigation.
The work also explores how variables such as needle geometry may influence plunger break-loose and extrusion forces. Understanding these relationships earlier can help development teams assess whether a proposed syringe configuration is appropriate for a particular drug formulation and intended delivery application.
Although the data is intended to support early evaluation and decision-making, the final suitability of a packaging system must still be established for the specific drug product and intended use.
Supporting Earlier Decisions in Injectable Drug Development
The pharmaceutical industry continues to develop biologics and other injectable therapies that require increasingly specialized packaging and delivery solutions. High-concentration formulations, sensitive active ingredients and more demanding administration requirements can increase the complexity of selecting appropriate container and closure components.
Packaging decisions made during early development can influence subsequent testing, technical evaluations and manufacturing preparations. If potential compatibility or functionality concerns are identified late in development, pharmaceutical companies may need to conduct additional studies or reconsider elements of the selected system.
The Aptar Pharma and Stevanato Group collaboration is intended to help address this challenge by providing system-level evidence earlier in the development process.
Access to assembled-system performance data can help pharmaceutical and biotechnology teams compare configurations, identify areas requiring further evaluation and focus resources on the most appropriate technical options. It can also support more productive discussions between drug developers and packaging suppliers by providing a common technical basis for assessing potential solutions.
For complex formulations, these early insights may be particularly valuable when selecting between coated and uncoated plungers, evaluating different syringe platforms or determining how a configuration may perform with a specific viscosity profile.
The companies also intend to make data packages and regulatory support services available to help pharmaceutical manufacturers throughout the product lifecycle. These resources are designed to complement the technical evaluations by helping customers organize and use relevant system-level information during development and subsequent regulatory activities.
The collaboration does not eliminate the need for drug manufacturers to perform product-specific assessments. Instead, it provides additional information that can help teams make better-informed decisions as they progress from initial feasibility studies toward scale-up and commercialization.
Executives Highlight the Value of Collaboration
Audrey Chardonnet, vice president of Global Market Development for Injectables at Aptar Pharma, emphasized the importance of combining the companies’ capabilities at the assembled-system level.
“We value our long-standing collaboration with Stevanato Group and the opportunity to bring our complementary expertise together at the assembled-system level,” Chardonnet said.
She explained that the joint work is intended to provide pharmaceutical development teams with earlier insights into component interactions and overall system performance, helping them make informed decisions during injectable product development.
Riccardo Marcon, senior vice president of Sales and Marketing for Drug Containment Solutions at Stevanato Group, also highlighted the growing need for system-level information as injectable therapies become more complex.
He noted that pharmaceutical companies require greater confidence in how packaging components function together as complete systems. By combining Stevanato Group’s expertise in prefillable containment solutions with Aptar Pharma’s knowledge of elastomeric components, the collaboration aims to deliver insights that support feasibility assessments, risk evaluation and development decisions.
The comments reflect the companies’ shared objective of helping customers evaluate packaging configurations as integrated systems rather than as collections of separate components.
Extending Aptar Pharma’s Integrated System-Level Framework
The collaboration represents one application of Aptar Pharma’s broader strategy to develop relationships with partners across the injectable value chain and expand the availability of integrated performance data.
Aptar Pharma’s injectable business combines more than 60 years of precision manufacturing experience with expertise that extends beyond individual components to the broader injectable system. The company works with pharmaceutical and biotechnology customers to address complex development challenges and support decision-making throughout the injectable drug development process.
Its system-level framework emphasizes the importance of considering component interactions, assembled-system functionality and relevant technical evidence when evaluating injectable packaging solutions.
Working with partners such as Stevanato Group enables Aptar Pharma to combine its own capabilities with complementary technologies and expertise. This approach can provide pharmaceutical customers with a more comprehensive view of potential system configurations and their performance characteristics.
As the collaboration progresses, system-level testing and data packages are expected to support technical discussions across the development lifecycle. However, pharmaceutical manufacturers remain responsible for demonstrating that their final drug product packaging and delivery systems are suitable for the intended application and comply with applicable regulatory requirements.
Advancing Pre-Filled Syringe Selection for Complex Therapies
The collaboration between Aptar Pharma and Stevanato Group highlights the growing importance of integrated packaging evaluation in modern injectable drug development. By combining glass syringe platforms, elastomeric components and system-level testing, the companies aim to give pharmaceutical developers earlier visibility into the performance of selected pre-filled syringe configurations.
The evaluation of 1 mL long and 2.25 mL formats, together with assessments of needle shield removal, plunger forces and sealing integrity, provides a technical foundation for comparing potential configurations.
For biotechnology and pharmaceutical companies developing sensitive biologics and other injectable medicines, these insights can help guide early feasibility assessments, support risk evaluation and inform subsequent development activities.
Through its integrated system-level framework and collaboration with Stevanato Group, Aptar Pharma is continuing to expand its approach to injectable packaging support. The initiative reinforces the value of combining component expertise with assembled-system performance data to help manufacturers navigate technical complexity and progress toward the development of suitable, reliable injectable drug delivery solutions.
