Aptar Pharma, a global leader in drug delivery, dosing, protection technologies and services, announced a collaborative system-level framework for injectable drug delivery systems. Building on more than a decade of supporting pharmaceutical customers in respiratory and ophthalmic drug development, Aptar Pharma will work with partners to develop data packages that combine integrated system-level testing and performance data for injectable therapies. Designed to provide earlier insight into assembled-system performance, these data packages help customers make more informed development decisions, better manage risk across development programs and support the delivery of safe and effective therapies to patients.

As biologics, sensitive vaccines and combination products evolve, pharmaceutical companies are seeking earlier insight into assembled-system performance to support development decisions and address the expectations of USP <382>.

Aptar Pharma’s Injectables division is built on more than 60 years of experience in elastomeric components for injectable drug delivery systems. By developing elastomeric solutions for these systems and working with leading partners across the injectable value chain, including pre-filled syringe (PFS) manufacturers, Aptar Pharma brings together partner collaboration, component expertise and integrated data to support customers throughout development. The current focus is on partner PFS platforms incorporating Aptar Pharma rigid needle shields (RNS) and PremiumCoat^® elastomeric plungers for sensitive drug formulations, including highly viscous biologics.

Container closure systems are often assessed component by component, requiring co-ordination across multiple suppliers and issue resolution as development progresses. This can make it challenging for customers to establish a complete view of assembled-system performance early in development. Aptar Pharma’s approach helps address this by supporting earlier system-level evaluations with partners and generating data on interactions between critical system components, in line with USP <382> principles.

Through its partner network, Aptar Pharma is developing data packages covering functional performance, container closure integrity testing (CCIT), sealing performance and component interactions to help customers:

• Support earlier container closure decisions with relevant system-level data
• Inform internal testing strategies in line with evolving USP <382> expectations
• Build confidence in assembled-system performance before late-stage scale-up.

Different biologics and vaccines require different system configurations depending on molecule characteristics, development pathways and manufacturing requirements.

This collaborative system-level framework is designed to support different development pathways through multiple supply options, established high-quality components and relevant performance data.

“As injectable therapies become more complex with the rise of biologics and combination products, USP <382> places greater emphasis on system-level understanding,” said Audrey Chardonnet, VP Global Market Development, Aptar Pharma Injectables. “Our approach is designed to help customers make more informed development decisions while preserving the flexibility required for different molecules and formats.”

Aptar Pharma’s framework is designed to support customers’ development decisions with system-level insights and data packages, while customers remain responsible for demonstrating the suitability and compliance of their final drug product packaging and delivery systems.