Lessons from the CAACB on the Prevention and Control of Adventitious Agent Contamination


Adventitious agent contamination of cell culture-based biomanufacturing operations for the production of protein and monoclonal antibody biotherapeutics are infrequent, but when they do occur, they are very costly, impact manufacturing operations, and can potentially impact patient safety and product supply. In response to this need, the MIT Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) began the confidential collection and analysis of industry-wide viral contamination data with an emphasis on “lessons learned”. The mission of the CAACB is to pool and to share knowledge, experience and practices in the area of adventitious agent contamination in biomanufacturing.  The Consortium is providing a safe and collaborative environment for networking and information exchange focused on identifying best industry practices in contamination response, corrective and preventive actions, and promoting the development of new technologies to detect adventitious agents and mitigate risk of contamination. This presentation will cover the learnings from this study, including identified industry risks and best practices to mitigate those risks. This talk will discuss some of the lessons learned from the collaborative work done by the CAACB and their implications for vaccine manufacture.