Selecting Container Closure Components with Confidence: Extractables and Leachables

Regulatory authorities require an Extractables and Leachables (E&L) risk assessment for all materials in contact with the drug product throughout the drug product’s lifecycle. Components used for primary packaging, like glass vials and rubbers stoppers, are commonly viewed as high risk due to the extended contact time between the components and the drug product. Leachable compounds from packaging components pose a risk to a drug’s quality and to patient safety. As a result, primary packaging components require a thorough assessment to ensure patient safety and drug product efficacy. Additionally, poor or incomplete assessments could lead to requests for significant rework and additional testing from regulatory authorities. 

The challenges with E&L assessments are multiple. Although there are published guidance documents (e.g., USP <1663>, USP <1664>, ISO-10993) and working groups in progress of publishing new guidance documents (ICH is currently working on updating ICH Q3E, the ICH guideline on Extractables and Leachables) there is no set prescription on how to execute an E&L assessment. Drug Packaging developers are under internal pressure to execute E&L studies that are often viewed as “checkbox” activities quickly and inexpensively while somehow still satisfying the scrutiny of regulatory bodies. 

In this webinar we will suggest a low-risk strategy for a complete E&L assessment on common components found in primary packaging. This strategy will include information to assist drug packaging developers with the many decisions they will need to make throughout the E&L assessment. The information will touch on both executing and planning the E&L risk assessment from a big picture down to details around the set-up, extraction techniques, analytical techniques and data interpretation required for both elastomers and glass. Additionally, exemplary results from case studies will be shared. 

If you work for a start-up or emerging company and are in the process of developing a biologic drug, don’t miss this opportunity to learn how to mitigate risk by planning and starting the assessment early to avoid mistakes that cause extra time, resources or even delays in approval.