The Practical Application of BPOG EL Protocols to Viral Clearance Filters

摘要

□egufatory guidance advocates virus control at various stages of the drug manufacturing process and directs that you test the capacity or the process to remove or inactivate virus. Patient safety concerns re □uire you to determine what impurities may be added by the virus control steps you implement. □hile the application of a standardized approach to identifying and □uantifying the e□ractables 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 poster will illustrate the practical implemention of standardized e□tractables method on an industry leading viral clearance technology by e□plaining the ratiooal for the selection of e□traction solvents□e □traction condition and sampling points. Data generated during the study is presented as well as lessons learned in implementing the new protocol.