PDA How will Rev. 2 of ICH Q5A affect the design of virus clearance studies

Since in 1999, the ICH Q5A (R1) has been one of the key guidelines that has shaped the design of virus clearance studies for recombinant protein products. It is anticipated that the draft of revision 2, expected to be issued later this year, will include a number of updates that may impact the design of virus clearance studies in the future.

Key aspects driving these changes are the use of new manufacturing technologies such as continuous processing and new modalities including cell and gene therapy vectors. The webinar will discuss these potential updates and review aspects such as the use of alternative virus spiking approaches to address clearance for continuous chromatography and how to build virus reduction capacity into the manufacturing process of viral vectors.