The updated ICH Q5A(R2) draft guidance has been released
PathoQuest, a leader in the development and provision of Next Generation Sequencing (NGS) testing services for the biopharmaceutical industry, is excited to announce that the updated ICH Q5A(R2) draft guidance for the “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin” has been release for public comment . This draft guidance firmly establishes the role value of NGS for viral safety testing. View the draft guidance here.
Contact us if you have a project you would like PathoQuest to evaluate or would like to align your testing with the 3Rs principles. Now with testing capabilities in both Europe (Paris) and in the U.S. (Wayne, PA).