Crystal Lake, Ill., July 17, 2026
Aptar Pharma announced the launch of a new integrated system-level framework designed to support injectable drug development by combining partner collaboration, system-level testing, and comprehensive performance data packages. The initiative aims to provide pharmaceutical companies with earlier insight into assembled drug delivery system performance, enabling more informed development decisions, improved risk management, and alignment with evolving USP <382> expectations for injectable drug delivery systems.
Supporting Development of Biologics and Advanced Injectable Therapies
As biologics, sensitive vaccines, and combination products become increasingly complex, developers require a more comprehensive understanding of how assembled container closure systems perform throughout development. Aptar Pharma’s new framework builds on more than 60 years of expertise in elastomeric components for injectable drug delivery and leverages collaborations with prefilled syringe manufacturers and other industry partners to evaluate complete system performance rather than individual components alone.
Integrated Testing Provides Earlier System-Level Insights
The framework combines functional performance testing, container closure integrity testing (CCIT), sealing performance, and evaluation of component interactions to generate integrated data packages for pharmaceutical developers. Initially, the program focuses on partner prefilled syringe platforms incorporating Aptar Pharma’s Rigid Needle Shields (RNS) and PremiumCoat® elastomeric plungers, particularly for sensitive and highly viscous biologic formulations. These data packages are designed to support earlier container closure decisions, strengthen internal testing strategies, and increase confidence before late-stage manufacturing scale-up.
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Flexible Approach Supports Evolving Regulatory Expectations
Aptar Pharma’s collaborative system-level strategy is intended to accommodate a wide range of biologics, vaccines, and injectable therapies requiring different packaging configurations and manufacturing pathways. The company plans to expand the initiative through additional industry partnerships and new performance data packages addressing various system configurations. By providing system-level insights while preserving flexibility for individual drug products, Aptar Pharma aims to help pharmaceutical companies streamline development and support the delivery of safe, effective injectable therapies for patients worldwide.
Source: Aptar Pharma press release
