October 18-21, 2015
Regulatory guidance advocates virus control at various stages of the drug manufacturing process and directs that you test the capacity of the process to remove or inactivate virus. Patient safety concerns require you to determine what impurities may be added by the virus control steps you implement. While the application of a standardized approach to identifying and quantifying the extractables from these steps has benefits when making comparisons, choices have to be made when developing the protocol that take into account the characteristics of the clearance device and use conditions This presentation will illustrate the practical implementation of standardized extractables method on an industry leading viral clearance technology by explaining the rational for the selection of extraction solvents; extraction conditions and sampling points. Data generated during the study will be presented as well as lessons learned in implementing the new protocol.
Paul Killian, Thomas Stone, and Jessica Shea, "The practical application of BPOG E&L protocols to viral clearance filters" in "Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications", Ekta Mahajan, Genentech, Inc., USA Gary Lye, University College London, UK Eds, ECI Symposium Series, (2015). http://dc.engconfintl.org/biopoly/36