Company: Boehringer Ingelheim
Liaison(s): Jon Coffman, Samantha Wang
Boehringer Ingelheim (BI), headquartered in Germany, is one of the world’s leading contract manufacturing organizations (CMO) and one of the largest privately held life science companies. BI has an established position in the biologics market having brought over 20 products successfully to the market for companies such as Amgen, Bayer, Genentech, and Pfizer. Overall, BI provides a comprehensive CMO platform with diverse capabilities from cell line development to product fill and finish, including the capacity to scale from clinical to commercial production. BI’s mission is to add value through innovation includes investigating the potential benefits of the perfusion process. The perfusion process offers an excellent solution for the manufacturing of unstable proteins. Perfusion allows proteins to be quickly removed from a cell culture bioreactor and stored under stable conditions for further processing rather than remaining in a potentially damaging cell culture environment. Furthermore, perfusion offers Boehringer Ingelheim the opportunity to reduce costs by using smaller scale bioreactors than the traditional setup for batch or fed batch cell cultivation. The goal of the BI TMP was: to grow and achieve a very high cell density on various cell lines; compare the retention analysis for the BI media versus commercial media; and, compare the density and product concentration of the fed-batch and perfusion process modes. Successful perfusion experimental runs, for baseline data analysis, were conducted during the fall semester using commercialized media on various CHO (Chinese Hamster Ovary) cells. During the spring semester, the team ran various experiments utilizing adapted cell lines and collected valuable information which provided insights into the advantages of the BI proprietary media over the commercial media. By demonstrating, via the perfusion process, the ability of multiple cell lines to reach and maintain a high density in the BI media, the BI Perfusion Process TMP validated important aspects of the perfusion process. Ultimately, this information provided BI with critical data which supported the potential of a universal mammalian cell perfusion platform for the manufacturing of pharmaceutical products.