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The Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB)

Safe and Reliable Manufacture of Biotherapeutics

One challenge in the safe and reliable production of biopharmaceuticals is mitigating the risk of cell culture contamination by adventitious agents such as viruses or mycoplasma. Currently, industrial knowledge about contaminating adventitious agents and successful approaches to combat these specific agents is largely limited to each company’s individual experience. As such, a central database of accumulated industry knowledge and experience does not exist. The collection, analysis and dissemination of the full body of industry experience would enhance the reliable manufacture and supply of such safe and effective medications.

Purpose and Outcome of the CAACB

The MIT CBI, along with several founding member companies, has launched the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB). The goals of the consortium are: the confidential collection and analysis of industry adventitious agent contamination data; and the dissemination of the most effective industry practices used to combat contaminations during the reliable manufacture of life-saving biotherapeutic medications. MIT is an ideal venue to host this initiative due to MIT’s existing track record with industrial collaborations and its strong faculty experience in solving complex systems engineering problems.

A comprehensive analysis of adventitious agent contamination data will be highly valuable as an industry “lessons learned” exercise. Such information should inform the industry on the best practices to mitigate the risks that lead to adventitious agent contamination. Specifically, the CAACB seeks to develop a comprehensive understanding of adventitious agents encountered, the source of such agents, and a risk-based analysis of the most effective barriers to contamination. The collection, analysis and dissemination of this information should enhance the uninterrupted supply of vital, safe and effective biotherapeutic medications. This is a goal shared by both the biopharmaceutical manufacturing industry and the CAACB as we strive to combat disease.
 
CAACB Consortium Concept