Reduction of product-related species during the fermentation and purification of a recombinant IL-1 receptor antagonist at the laboratory and pilot scale (pages 946–956)
Dr. Emily B. Schirmer, Kathryn Golden, Jin Xu, Jesse Milling, Alec Murillo, Patricia Lowden, SriHariRaju Mulagapati, Jinzhao Hou, Joseph T. Kovalchin, Allyson Masci, Kathryn Collins and Gregory Zarbis-Papastoitsis
Article first published online: 2 AUG 2013 | DOI: 10.1002/biot.201300189
Tracking product quality through process development for both upstream and downstream operations is a useful tool to process engineers in biologics development and scale-up. In this study, authors take a parallel approach to reduce undesired product-related species by modulating host cell enzymatic activity during fermentation and by exploiting small biochemical differences during purification. By designing robust upstream and downstream processes based on maintaining high levels of product quality, the authors demonstrate the ability of the process to produce quality drug substance at laboratory and commercial scales.