Aptar Pharma Launches Integrated System-Level Framework to Support Injectable Drug Development
核心洞察
Aptar Pharma (搜索) announced a collaborative system-level framework for injectable drug delivery systems, combining partner collaboration with integrated testing and performance data packages.
The framework is designed to provide earlier insight into assembled-system performance, helping pharmaceutical companies make more informed development decisions and manage risk.
The initiative addresses evolving USP <382> expectations, which place greater emphasis on system-level understanding for complex injectable therapies including biologics and combination products.
Aptar Pharma (搜索), a global leader in drug delivery, dosing, protection technologies and services, today announced a collaborative system-level framework for injectable drug delivery systems. The initiative, unveiled from the company's Crystal Lake, Illinois headquarters, builds on more than a decade of experience supporting pharmaceutical customers in respiratory and ophthalmic drug development and aims to address the growing complexity of injectable therapies.
The framework combines partner collaboration, system-level testing, and performance data packages to provide earlier insight into assembled-system performance. These data packages are designed to help pharmaceutical customers make more informed development decisions, better manage risk across development programs, and support the delivery of safe and effective therapies to patients.
Addressing Evolving USP <382> Expectations
As biologics, sensitive vaccines, and combination products continue to evolve, pharmaceutical companies are increasingly seeking earlier insight into assembled-system performance. The framework directly responds to the expectations outlined in USP <382>, which places greater emphasis on system-level understanding of container closure systems.
"Container closure systems are often assessed component by component, requiring co-ordination across multiple suppliers and issue resolution as development progresses," the company noted. This fragmented approach can make it challenging for customers to establish a complete view of assembled-system performance early in development. Aptar Pharma (搜索)'s framework addresses this gap by supporting earlier system-level evaluations with partners and generating data on interactions between critical system components, in line with USP <382> principles.
Leveraging Six Decades of Elastomeric Expertise
Aptar Pharma (搜索)'s Injectables division is built on more than 60 years of experience in elastomeric components for injectable drug delivery systems. The company develops elastomeric solutions and works with leading partners across the injectable value chain, including pre-filled syringe (PFS) manufacturers.
The current focus is on partner PFS platforms incorporating Aptar Pharma (搜索) rigid needle shields (RNS) and PremiumCoat (搜索)® elastomeric plungers for sensitive drug formulations, including highly viscous biologics. Through its partner network, Aptar Pharma is developing data packages covering functional performance, container closure integrity testing (CCIT), sealing performance, and component interactions.
These data packages are designed to help customers support earlier container closure decisions with relevant system-level data, inform internal testing strategies in line with evolving USP <382> expectations, and build confidence in assembled-system performance before late-stage scale-up.
Flexibility Across Development Pathways
Different biologics and vaccines require different system configurations depending on molecule characteristics, development pathways, and manufacturing requirements. The 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 (搜索) 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 (搜索) emphasized that its 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.
Next Steps
Aptar Pharma (搜索) plans to progressively introduce other partner collaborations and supporting data packages as part of this approach, with each initiative designed to address specific system configurations and development needs across biologics and vaccine applications.