Product Quality Considerations for Mammalian Cell Culture Process Development and Manufacturing

2013 ◽  
pp. 123-166 ◽  
Author(s):  
Michael J. Gramer
Keyword(s):  
Cell Culture ◽  
Product Quality ◽  
Mammalian Cell ◽  
Process Development ◽  
Mammalian Cell Culture ◽  
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.

Microwell engineering characterization for mammalian cell culture process development

2010 ◽  
Vol 105 (2) ◽  
pp. 260-275 ◽  
Author(s):  
Timothy A. Barrett ◽  
Andrew Wu ◽  
Hu Zhang ◽  
M. Susana Levy ◽  
Gary J. Lye
Keyword(s):  
Cell Culture ◽  
Mammalian Cell ◽  
Process Development ◽  
Mammalian Cell Culture ◽  
Cell Culture Process ◽  
Culture Process
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