Extractables and Leachables

Mitigate risk in bioprocessing

Assessment of extractables and leachables (E&L) is a key element of demonstrating equipment suitability in order to move a new drug molecule candidate through the clinical development process.

Streamline your process by working with our Fast Trak scientists, experienced in extractables and leachables study design, testing, and data analysis.

Support for your E&L evaluation

Take advantage of our extensive analytical expertise to ensure you have fully comprehensive E&L data for your regulatory submission. In alignment with industry guidance, we provide high-quality standardized extractables data packages for our products to facilitate your equipment suitability assessment. If the standard extractables packages aren’t a fit for your needs, we offer end-to-end E&L support services.

Custom E&L studies

If your process conditions fall outside of a standard test protocol, or if a leachables study is needed after performing a risk assessment, we can design and conduct a custom study using multiple, orthogonal analytical techniques. Leachables studies can be based on simulations or use your actual process to generate your data. We also offer toxicological risk assessment support for your patient safety assessment and to evaluate the need for further extractables or leachables analysis.

Why choose Fast Trak for E&L support?

We are committed to bioprocess – We are actively involved in industry working groups, such as BioPhorum, to influence and stay up-to-date with industry guidance
We know the materials inside and out – Materials science and analytical testing are an integral part of product development, and we use this knowledge to design E&L studies that meet your unique needs
One size does not fit all – We customize every study we develop based on the objective and potential risk, the complexity of the study, and the needed data

Related services

Speed to market is critical

If you’re looking to launch a new molecule, enhance existing capacity, or develop biosimilars, our Fast Trak portfolio of services is designed to take you from molecule to market and anywhere in between.

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Extractables & Leachables Services