Extractables and leachables are product-related impurities that result from product contact with components, such as gaskets, stoppers, storage bags, cartridges and prefilled syringes that are used for processing, storage, and/or delivery of biopharmaceuticals. Leachables are of concern for patients due to potential effects on product quality and safety. It is possible that such an impurity could directly impact the patient or indirectly impact the patient by interacting with the protein by chemical reactions. Adducts and leachables may or may not be detected as product-related impurities in leachables screening stability studies depending on the rigor of the analytical program.
At this year’s Extractables and Leachables Summit, Dr Andreas Nixdorf, Business Development Manager Extractables & Leachables Testing at SGS Life Science Services in Germany, will be presenting on leachables strategies for finished biopharmaceuticals.
His presentation will cover:
- The need to develop a thorough and holistic extractable and leachable program based on risk assessment, review of existing literature, and consolidation of industry best practices
- The different stages of risk mitigation strategies for an extractable-leachable program
- The integration of analytical activities with health-based risk-assessment information into the design of an extractable-leachable program
For further information on the 2019 Extractables and Leachables Summit, download the agenda.
For further information, please contact:Josée Leach
Global Marketing Manager – SGS Life Sciences
t: +44 7889 939 512