RT Journal Article SR Electronic T1 MIT CAACB Risk Assessment Case Study: Assessing virus cross-contamination risk between two simultaneous processes in an open biomanufacturing facility JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP pdajpst.2021.012691 DO 10.5731/pdajpst.2021.012691 A1 Andrea L. Koenigsberg A1 Veronica Fowler A1 Reuben Domike A1 Audrey Brussel A1 Paul W Barone A1 Flora J Keumurian A1 James Leung A1 Michael E. Wiebe A1 Michael T. Brewer A1 Shawn Chan A1 Nicolas Dumey A1 Anne Fournillier A1 Marcella Goodnight A1 Johanna Kindermann A1 Richard Leavy A1 Buyoung Lee A1 Stefan Minning A1 Marie Murphy A1 Eric Myers A1 Armen Nahabedian A1 Kavita Nanda A1 Sandi Parriott A1 GK Raju A1 Ciaran Scallan A1 Stephanie Schoch A1 Joe Shiminsky A1 Bonnie Shum A1 Sebastian Teitz A1 Bernice Westrek A1 Stacy Springs YR 2022 UL http://journal.pda.org/content/early/2022/10/14/pdajpst.2021.012691.abstract AB Some members of MIT′s Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) previously published content on the ″Quality Risk Management in the Context of Viral Contamination″ which described tools, procedures, and methodologies for assessing and managing the risk of a potential virus contamination in cell culture processes. To address the growing industry interest in moving manufacturing towards open ballrooms with functionally closed systems and to demonstrate how the ideas of risk management can be leveraged to perform a risk assessment, CAACB conducted a case study exercise of these new manufacturing modalities. In the case study exercise, a cross-functional team comprised of personnel from many of CAACB's industry membership collaboratively assessed the risks of viral cross-contamination between a human and non-human host cell system in an open manufacturing facility. This open manufacturing facility had no walls to provide architectural separation of two processes occurring simultaneously, specifically a recombinant protein perfusion cell culture process using the human cell line, HEK-293 (Process 1) and a downstream post-viral filtration unit operation (Process 2) of a recombinant protein produced in CHO cells. This viral risk assessment focused on cross-contamination of the Process 2 filtration unit operation after the Process 1 perfusion bioreactor was contaminated with a virus that went undetected. The workflow for quality risk management that is recommended by the International Council for Harmonisation (ICH) was followed, which included identifying and mapping the manufacturing process, defining the risk question, risk evaluation and risk control. The case study includes a completed Failure Mode and Effects Analysis (FMEA) to provide descriptions of the specific risks and corresponding recommended risk reduction actions.