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Extractables, Leachables, and Better Risk Mitigation

New regulations in the US extractables and leachables (E&L) market has forced companies to sharpen their understanding of evolving E&L regulatory expectations more than ever. However, as Fran DeGrazio suggests, there is still much to be done to understand the process of E&L analysis and achieve standardisation across the board.

The process of E&L analysis should begin promptly, as she explains: “The extractables work should start in Phase II of drug development, once materials have been characterised and the appropriate final components chosen. When this work is completed, a risk assessment should be performed to understand which extractables should be specifically looked for in the leachables studies. Leachables work must be done with fully validated test methods; the earlier the work gets started, the better to ensure that proper data is generated in a timely fashion. These studies should occur in Phase III development. This data is then available to support the drug approval application process.”

Even though this is a seemingly straightforward process, DeGrazio says the biggest challenge in E&L analysis over the last decade has been misunderstanding. “Although it seems relatively simple for those who are experts in this space, one of the biggest challenges that we have seen is the true understanding of the difference between extractables and leachables studies and how they relate.”

The extractables and leachables phases should be understood as two very different but related steps, both necessary to provide a complete, scientifically sound data package.

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Fran DeGrazio has over 35 years of experience in the pharmaceutical packaging and delivery industry with extensive expertise in injectable drug products, including vial container closure systems and prefillable systems for combination products. Fran has held numerous technical roles at West Pharma, including R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories and Scientific Affairs. In her current role as Chief Scientific Officer she is responsible to leverage scientific and regulatory understanding across the enterprise. Fran received the Philadelphia Business Journal 2018 Healthcare Innovators of the Greater Philadelphia Region Award and the Healthcare Business Woman’s Association Luminary Award for West in 2017.
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Fran DeGrazio
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