By Donald DeCou, Technology Manager, Extractables and Leachables, and Matthew Woods, Manager, Extractables and Leachables
Demonstrating the compatibility of any material that comes in contact with a drug product throughout its lifecycle (manufacture, containment, and delivery) is a requirement for any regulatory submission. Agency expectations on this material evaluation, defined as extractables and leachables (E/L), continue to evolve and expand. Extractables and leachables assessments of pharmaceutical packaging and delivery systems are critical to both your development and regulatory submissions.
These newer companies are often at a disadvantage from larger companies since they do not have the ability to leverage historical E&L data or the advantage that comes with a platform approach to containment needs. Unfortunately, West sees a pattern where new and emerging pharmaceutical companies wait until the end of Phase III to start planning their E/L testing program. Waiting this late in development can lead to increased costs and delays, stemming from poor assessments that are questioned by the reviewer, or incomplete submissions that require the drug company to redo or execute additional work.
To meet regulatory expectations, the mindset around E/L testing must change from “How quickly can we get extractable and leachables testing done?” to “Is it too soon to start my extractables and leachables assessment?”
This article summarizes what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.