Environmental Analysis Of Therapeutic hMSC Manufacturing: A Comparison Of Multiple Bioprocess Systems

By Omokhowa Agbojo, Maya Lim, & Josephine Lembong

The oil & gas, electric utilities, agriculture, and metal manufacturing industries are often cited when discussing those that have significant negative impacts on the environment. However, biotechnology is rarely mentioned in the same category as these industries. Large scale therapeutic cell manufacturing, particularly hMSC manufacturing, is a ready topic for environmental impact, as there are now over 10 hMSC therapeutic products available commercially around the globe and over 40 late-stage clinical trials with multiple more market approvals likely in the next few years.

In the Fall of 2020, RoosterBio partnered with the University of California, Berkeley Fung Institute’s Master of Engineering program to launch a study into the environmental impacts of human mesenchymal stromal/stem cell (hMSC) manufacturing. The motivation behind this project was not only to understand and quantify the levels of impact of cell therapy manufacturing but also to heighten our awareness of such impacts in years to come. In this project, the environmental impact of hMSC manufacturing has been quantified at two different clinically relevant scales and in three different configurations for production.