Ensuring drug product quality goes beyond the active ingredient—it requires understanding how packaging and process‑contact materials interact with the formulation. As therapies become more sensitive and regulatory expectations rise, Extractables and Leachables (E&L) assessment has become essential. When applied strategically and early, E&L studies help anticipate risks, guide packaging selection, reinforce Quality by Design (QbD), and prevent costly delays. This article highlights how proactive E&L evaluation de‑risks drug development, supports regulatory readiness, and how an integrated partner like Aragen can streamline this critical process.
Any modification to a drug product’s container closure system—whether a change in material composition, supplier, sterilization process, or manufacturing condition—triggers regulatory expectations to assess the impact on product quality and patient safety. Health authorities require sponsors to demonstrate that such changes do not introduce harmful impurities or compromise product stability.
However, in many development programs, extractables and leachables (E&L) studies are initiated only after packaging components have been finalized and manufacturing scale-up is well underway. When unexpected impurities are detected at this stage, the consequences can include additional stability studies, reformulation, packaging redesign, or delays in regulatory submissions.
Extractables and leachables represent potential chemical migrants from packaging and process-contact materials into the drug product. Extractables studies identify compounds that may be released under exaggerated laboratory conditions, creating a worst-case profile of material risk. Leachables studies confirm which of those compounds migrate under real-world storage and usage conditions.
These studies are particularly critical for parenteral, ophthalmic, inhalation, and biologic products, where even trace-level impurities may affect safety, stability, or efficacy. A structured E&L strategy helps sponsors answer essential questions:
When approached proactively, E&L assessment becomes a powerful tool for identifying impurity pathways early and mitigating risk before it escalates into a regulatory concern.
Integrating extractables and leachables evaluation early in development strengthens Quality by Design (QbD) principles. Rather than treating E&L as a late-stage compliance activity, forward-thinking programs incorporate material risk assessment, analytical characterization, and toxicological evaluation during formulation development and container selection.
A risk-based, phase-appropriate strategy ensures that testing scope aligns with product complexity and development stage. Early insights from extractables profiling can guide packaging selection, inform stability strategy, and reduce the likelihood of unexpected findings during pivotal studies. This alignment not only enhances regulatory confidence but also supports more predictable timelines.
Selecting a CDMO with comprehensive E&L capabilities can significantly streamline this process. When extractables profiling, leachables monitoring, analytical method development, toxicological assessment, and regulatory documentation are coordinated within a unified development framework, the resulting efficiencies are substantial.
An integrated approach allows E&L insights to be directly applied across formulation development, stability programs, and submission strategy. This reduces duplication of work, minimizes communication gaps, and ensures impurity risk is evaluated within the broader context of product performance and lifecycle management.
At Aragen Life Sciences, Extractables & Leachables studies are designed to provide both scientific depth and regulatory confidence. Our comprehensive solutions combine advanced analytical platforms—including GC-MS, LC-MS, and ICP-MS—with phase-appropriate study designs tailored to small molecules and biologics alike.
By integrating material risk assessment, exhaustive extractables characterization, real-time leachables monitoring, and toxicological evaluation under one roof, Aragen enables sponsors to embed E&L considerations seamlessly into their development programs. This cohesive approach minimizes impurity-related risks, strengthens regulatory submissions, and supports a smoother transition from development to commercialization.
In today’s evolving regulatory landscape, proactive control and monitoring of extractables and leachables is no longer optional. It is a foundational element of safeguarding drug product quality. When addressed strategically—and integrated early—E&L assessment transforms from a potential obstacle into a competitive advantage. Through scientific rigor, cross-functional expertise, and an end-to-end development platform, Aragen helps sponsors move forward with confidence, ensuring that packaging and process materials support, rather than compromise, product success.
