Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10235932 | Process Biochemistry | 2012 | 8 Pages |
Abstract
⺠A fed-batch process for the production of biosimilar monoclonal antibody has been developed. ⺠Impact of process change from perfusion to fed-batch on product quality and cell performance was investigated. ⺠There were no significant quality changes during process transition from perfusion to fed-batch. ⺠Through scale-up study from 3 L to 12,500 L, it was confirmed that cell performance and product quality could be maintained. ⺠Product quality from fed-batch process was comparable to that of perfusion process as well as reference product.
Related Topics
Physical Sciences and Engineering
Chemical Engineering
Bioengineering
Authors
Soo-Young Lee, Young-Bum Kwon, Jong-Moon Cho, Keun-Hee Park, Shin-Jae Chang, Dong-Il Kim,