Aptar Pharma has launched a collaborative system-level framework designed to support the development of injectable drug delivery systems.
The framework will enable pharmaceutical partners to access integrated data packages combining system-level testing and performance data for injectable therapies.
Aptar Pharma stated that demand for earlier insight into the performance of assembled drug delivery systems is increasing, particularly as biologics, sensitive vaccines, and combination products become more prominent.
The company highlighted that pharmaceutical firms are seeking to address requirements such as those set out by United States Pharmacopeia (USP) <382>, which covers container closure systems for injectable drugs.
The framework brings together Aptar Pharma’s experience in elastomeric components with a network of partners across the injectable drugs sector.
This includes collaboration with pre-filled syringe manufacturers and critical device component suppliers.
Aptar Pharma’s current initiatives focus on partner pre-filled syringe platforms that incorporate its rigid needle shields and PremiumCoat elastomeric plungers. These are aimed at supporting formulations such as highly viscous biologics.
Through its partner network, the company is developing data packages that include information on functional performance, container closure integrity testing, sealing, and component interactions.
These data are intended to help customers make earlier container closure decisions, inform internal testing strategies, and build confidence in system performance before moving to large-scale production.
Aptar Pharma Injectables global market development vice-president Audrey Chardonnet said: “As injectable therapies become more complex with the rise of biologics and combination products, USP <382> places greater emphasis on system-level understanding.
“Our approach is designed to help customers make more informed development decisions while preserving the flexibility required for different molecules and formats.”
Aptar Pharma indicated that it plans to introduce further collaborations and additional data packages to address varied system configurations and development needs for biologics and vaccine applications.
