Effect of ambient light on monoclonal antibody product quality during small-scale mammalian cell culture process in clear glass bioreactors

2014 ◽  
Vol 30 (3) ◽  
pp. 562-570 ◽  
Author(s):  
Mary Mallaney ◽  
Szu-han Wang ◽  
Alavattam Sreedhara
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibody ◽  
Product Quality ◽  
Mammalian Cell Culture ◽  
Small Scale ◽  
Cell Culture Process ◽  
Ambient Light ◽  
Clear Glass ◽  
Culture Process ◽  
Monoclonal Antibody Product

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.

Validation of TSE Agent Removal by Immunoaffinity and Ion Exchange Chromatography Steps of the ReFacto Manufacturing Process.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4172-4172
Author(s):  
James Booth ◽  
Molly Tannatt ◽  
Steve Vicik ◽  
Brian Kelley
Keyword(s):  
Cell Culture ◽  
Manufacturing Process ◽  
Mammalian Cell Culture ◽  
Transmissible Spongiform Encephalopathy ◽  
Production Equipment ◽  
Exchange Chromatography ◽  
Cell Culture Process ◽  
Spongiform Encephalopathy ◽  
Fractionation Process ◽  
Culture Process

Abstract ReFacto® (moroctocog alfa), a recombinant Factor VIII approved for treatment of hemophilia A is produced by a mammalian cell culture process that includes therapeutic-grade human serum albumin (HSA) in the cell culture medium. The plasma-derived HSA used in the cell culture process is sourced from countries whose blood supply does not pose a significant transmissible spongiform encephalopathy (TSE) risk, and is manufactured utilizing a fractionation process that has demonstrated the capability to significantly reduce the level of experimentally added TSE infectivity. While to date, no case of TSE has been identified with a history of exposure to fractionated HSA, Wyeth has conducted a study to demonstrate that the ReFacto manufacturing process has significant capacity to remove a TSE agent if it were present in the HSA. The ReFacto purification process consists of five chromatographic steps, two of which were validated for removal of a TSE agent: the immunoaffinity step (8A4 Sepharose chromatography) and anion exchange step (Q Sepharose chromatography). The GLP study was performed using appropriately qualified lab-scale systems, which model the performance of the production equipment. Brain homogenates from scrapie-infected hamsters (263K strain) were added to loads of the respective chromatography steps and levels of the scrapie agent in the product pools were determined using a validated Western blot quantitation method. Duplicate runs were performed to assess the consistency of the TSE agent reduction. The results show that both chromatography steps provide significant clearance of the TSE agent, with greater than a billion-fold (9 log) reduction in infectivity provided by the two process steps in combination. The consistency of the duplicate run results was very good (less than 0.7 log difference between runs). While the risk of TSE contamination of HSA is only theoretical, these data provide a high degree of assurance that in the event of an adventitious TSE contamination of the HSA used in the ReFacto cell culture process, the purification steps would remove the infectious agent to safe levels.

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

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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