BioMAN Activities – Research Area 3

Assess and mitigate risk in biopharmaceutical production

Biopharmaceutical development and production face manifold quality, safety and financial risks throughout all stages of a therapeutic’s life cycle. The lack of predictive, pre-clinical tools for toxicity or immunogenicity increases risk and cost during therapeutic development. Poor understanding of how bioprocess decisions affect final protein quality increases production risks. A lack of shared industry knowledge about the most effective methods to detect and prevent adventitious agent contamination increase the risk of low frequency, high impact contaminations that could result in product stock-out or a patient safety catastrophe. And finally, the choice of manufacturing location or partnering strategy imposes financial and supply chain risks. MIT BioMAN is working to understand these and other risks facing biopharmaceutical development and manufacture, and to develop technologies and strategies to mitigate these risks. Specific research programs in Theme 3 are focused on:
 

Deeper Process Understanding

BioMAN research is focused on leveraging new technologies to understand how process conditions (e.g. production clone type, genetic character and culture conditions), from single-cells to populations of cells to whole animals, relate to risk associated with a biotherapeutic’s quality, immunogenicity and efficacy.

 

Tools to Aid Decision Making

BioMAN research is focused on the development of simulation models to aid in: decision-making processes for choosing global manufacturing locations, capacity utilization for existing networks, determining value of incorporating Contract Manufacturing Organizations (CMOs) and economic projections in the presence of biosimilars.

 

Analyzing Contamination

BioMAN research is focused on the analysis of adventitious agent contamination in cell-based production of antibodies, therapeutic proteins and vaccines and development of risk-based strategies, best practices and assessment of the technology needs. (Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB)).