The MIT / Industry Initiative on Preventing Adventitious Agent Contamination in Biomanufacturing
Michael E. Wiebe, PhD
Quantum Consulting, LLC
Adventitious agent contamination of cell culture based biomanufacturing operations have occurred on a number of occasions in the past. Although these contaminations are relatively infrequent, when they occur they could have potential impact on patient safety and product supply, and are very costly. An industry consortium, the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) has been formed under the auspices of MIT’s Center for Biomedical Innovation. 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.
The inaugural project now in progress is the confidential collection and analysis of industry-wide viral contamination data with an emphasis on “lessons learned”. Specifically the project seeks to identify industry risks as well as effective barriers to those risks. Progress on this project and future directions of the Consortium will be discussed. Eighteen companies have now joined and support the Consortium as either Full Members (biomanufacturers) or Associate Members (companies supporting biomanufacturers). Membership remains open to companies interested in the integration and sharing of knowledge of best industry practice, and developing new technologies to mitigate the risk of adventitious agent contamination.