Biopharmaceutical Manufacturing: Current Titers and Yields in Commercial-Scale Microbial Bioprocessing

by Ronald A. Rader and Eric S. Langer
Volume 14, Issue 4 (Winter 2015/2016)

This article reports the average titers and yields currently attained with commercially manufactured biopharmaceuticals expressed by microbial systems such as E. coli and yeasts. A recent BioProcessing Journal article comparably covered results from the first phase of this study concerning historical titers and yields attained for commercial-scale biopharmaceutical production using mammalian cells (e.g., CHO). As with this prior mammalian component, public domain data concerning titers and yields attained with microbially manufactured products were obtained using all available sources. These included a review of available literature and direct contact with over 200 bioprocessing professionals identified as involved in relevant product research and development, and manufacturing. Unexpectedly, current microbial titers with commercially manufactured products were found to be consistent with those previously determined for mammalian products. However, purification yields attained with microbial manufacturing averaged only about 15%. This is much lower than with mammalian products yielding approximately 69%. Despite low downstream yields, microbial bioproduction continues to be considered less costly, simpler, faster, and generally more economical than mammalian manufacturing...

Rader RA, Langer ES. Biopharmaceutical manufacturing: current titers and yields in commercial-scale microbial bioprocessing. BioProcess J, 2016; 14(4): 51–5.

Posted online January 12, 2016.