Extractable and leachable (E&L) compounds associated with the use of polymeric single-use systems (SUS) are of primary concern due to their direct impact on product and patient safety. The 2014 Biophorum extractables protocol provided a standardized framework to conduct E&L testing and has been widely used by SUS suppliers as well as the end-user biomanufacturing companies. Since its implementation, several concerns associated with the testing methods proposed in the protocol have been raised by testing laboratories. A comprehensive review of the data generated using the 2014 BioPhorum extractables protocol was initiated by Biophorum’s Extractables and Leachables workstream to mitigate these concerns.
This document aims to summarize the findings of the data review and make scientific, data-driven recommendations to address specific concerns about extraction solvents and testing timepoints. This review established that certain extraction solvents (5M Sodium Chloride and 1% Polysorbate 80) and timepoints (Time 0) proposed in the testing matrix of the 2014 protocol added limited value to determination of the full extractables profile. Such trends were
observed for organic and elemental extractables alike. Based on these findings, specific recommendations about elimination of these solvents and timepoints are outlined in this document.