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In this hour-long session, delegates will be given the opportunity to pre-submit questions which will then be posed to the regulators and key leaders in the industry. Topics covered historically include:
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. To support the biopharmaceutical manufacturing industry the Consortium on Adventitious Agent Contamination (CAACB) at MIT have conducted a number of projects with the goal of identifying best practices in the control and prevention of adventitious agent contamination. These projects include collecting data on industry wide viral contamination experience, collecting data on the effectiveness of media treatment technologies, and identification of industry wide facility segregation approach. This presentation will highlight the key lessons that the CAACB has learned from its current activities.