Robust factor selection in early cell culture process development for the production of a biosimilar monoclonal antibody

2016 ◽  
Vol 33 (1) ◽  
pp. 181-191 ◽  
Author(s):  
Michael Sokolov ◽  
Jonathan Ritscher ◽  
Nicola MacKinnon ◽  
Jean-Marc Bielser ◽  
David Brühlmann ◽  
...  
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibody ◽  
Process Development ◽  
Cell Culture Process ◽  
Culture Process

Miniature Bioreactors for Rapid Bioprocess Development of Mammalian Cell Culture

2012 ◽  
Vol 59 (1) ◽  
Author(s):  
Mohd Helmi Sani ◽  
Frank Baganz
Keyword(s):  
Cell Culture ◽  
Mammalian Cell ◽  
Process Development ◽  
Mammalian Cell Culture ◽  
Small Scale ◽  
Cell Culture Process ◽  
Deep Wells ◽  
Working Volume ◽  
Culture Process ◽  
And Control

At present, there are a number of commercial small scale shaken systems available on the market with instrumented controllable microbioreactors such as Micro–24 Microreactor System (Pall Corporation, Port Washington, NY) and M2P Biolector, (M2P Labs GmbH, Aachen, Germany). The Micro–24 system is basically an orbital shaken 24–well plate that operates at working volume 3 – 7 mL with 24 independent reactors (deep wells, shaken and sparged) running simultaneously. Each reactor is designed as single use reactor that has the ability to continuously monitor and control the pH, DO and temperature. The reactor aeration is supplied by sparging air from gas feeds that can be controlled individually. Furthermore, pH can be controlled by gas sparging using either dilute ammonia or carbon dioxide directly into the culture medium through a membrane at the bottom of each reactor. Chen et al., (2009) evaluated the Micro–24 system for the mammalian cell culture process development and found the Micro–24 system is suitable as scaledown tool for cell culture application. The result showed that intra-well reproducibility, cell growth, metabolites profiles and protein titres were scalable with 2 L bioreactors.

Evaluating the impact of cell culture process parameters on monoclonal antibody N-glycosylation

2014 ◽  
Vol 188 ◽  
pp. 88-96 ◽  
Author(s):  
Marija Ivarsson ◽  
Thomas K. Villiger ◽  
Massimo Morbidelli ◽  
Miroslav Soos
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibody ◽  
Process Parameters ◽  
Cell Culture Process ◽  
Culture Process ◽  
The Impact
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