Pavan Hemmege Venkatappa

GLP-1 formulations are not standard injectables Liraglutide, semaglutide, tirzepatide and the molecules following them present chemical sensitivity profiles that materially affect their interaction with primary packaging. Compared with conventional small‑molecule injectables, the impact of: extractables from elastomeric components silicone oil particles from plunger coatings surface interactions at the stopper–drug interface may be amplified.

The regulatory position From a regulatory standpoint, elastomeric components are expected to be assessed for biosimilars using the same core principles applied to originator products - covering functional suitability, extractables and leachables (E&L), and container closure integrity (CCI). USP <382> outlines an approach to functional suitability assessment of elastomeric components for injectable drug products.

In the evolving landscape of pharmaceutical packaging, ensuring the integrity and functionality of Container Closure Systems (CCS) requires a shift from isolated component testing to a holistic, system-based approach, highlighted by the USP<382> implementation. This presentation explores how systems thinking enhances the qualification of primary packaging for injectable drugs, bridging the regulatory & qualification requirements to real-world performance expectations.