Pathogen safety in biopharma: sequencing to come

Abstract

Testing for adventitious viruses is critically important for biopharmaceutical quality control to guarantee patient safety. There have, however, been a few reported instances where traditional in vivo and in vitro adventitious agent test (AAT) approaches have failed, as later recognized using next-generation sequencing (NGS). The recent revision of the ICH Q5A guideline now support the use of NGS to complement or even to replace existing in vivo and in vitro AAT methods. Consequently, strategies to maximize the virus safety margins of biopharmaceuticals are being redefined. We now witness the replacement of in vivo AAT methods, driven also by the 3R principles, as well as attempts to complement in vitro AAT methods by NGS. Longer term, it is to be expected that NGS will be a reliable and potentially broader and equally sensitive replacement for in vitro AAT methods.

Biography

Beyond his work at Takeda, Dr. Thomas Kreil is Chairman of the Plasma Protein Therapeutics Association’s (PPTA) Pathogen Safety Steering Committee, a Steering Committee member of the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB), as coordinated by the Massachusetts Institute of Technology (MIT). He is also an Associate Professor at the Institute of Virology, Medical University of Vienna, Austria.