Kymos Group provides GMP-certified extractables and leachables (E&L) testing services in accordance with relevant pharmacopoeia and regulatory expectations, and fully integrated within broader CMC analytical activities.
Our E&L studies support pharmaceutical and biotechnology companies in the characterization of extractables and leachables originating from packaging systems, container closure systems, and manufacturing components that come into contact with the drug product during storage and/or use, ensuring product quality and patient safety.
Taking advantage of our state-of-the-art analytical instrumentation and strong regulatory expertise, Kymos applies a case-by-case, risk-based approach to define appropriate study designs, extraction conditions, analytical techniques, and safety thresholds for each specific manufacturing setup.
How we Design Extractables & Leachable Studies
Our extractables and leachables studies are designed following a scientifically justified and regulatory-driven approach, aligned with current guidelines and pharmacopoeial requirements, including ICH Q3E.
- Risk-based assessment of materials and components in contact with the drug product
- Definition of appropriate extraction conditions (solvents, temperature, duration)
- Selection of analytical scope based on expected compound classes
- Definition of safety thresholds and reporting limits
- Adaptation of study design to early or late stage development needs
This approach ensures that our studies generate relevant, interpretable, and regulatory-acceptable data, supporting both development decisions and regulatory submissions.
Analytical Techniques for Extractables & Leachables
We have developed the following methodology to analyze extraction solutions by LC/MS, GC/MS, LC/UV:
Extractables & Leachables in Single-Use Systems
We design and execute extractables and leachables studies for single-use systems, aligned with current regulatory expectations and relevant pharmacopoeial guidance, including USP <665> and <1665>.
- Risk-based assessment of single-use system components
- Study designs adapted to single-use materials
- Analytical characterization of potential extractables and leachables
- Support for qualification and risk assessment of single-use systems
This approach supports the use of single-use systems across development and manufacturing activities, particularly in biologics and advanced therapy products.
Why partner with Kymos for your E&L Studies?
Services
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