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Effect of process change from perfusion to fed-batch on product comparability for biosimilar monoclonal antibody

✍ Scribed by Soo-Young Lee; Young-Bum Kwon; Jong-Moon Cho; Keun-Hee Park; Shin-Jae Chang; Dong-Il Kim


Book ID
116845680
Publisher
Elsevier Science
Year
2012
Tongue
English
Weight
543 KB
Volume
47
Category
Article
ISSN
1873-3298

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## Abstract This case study focuses on the scale‐up of a Sp2/0 mouse myeloma cell line based fed‐batch bioreactor process, from the initial 3‐L bench scale to the 2,500‐L scale. A stepwise scale‐up strategy that involved several intermediate steps in increasing the bioreactor volume was adopted to