Process Development Considerations for Therapeutic Monoclonal Antibodies in Mammalian Cell Culture

2007 ◽  
pp. 451-478
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibodies ◽  
Mammalian Cell ◽  
Process Development ◽  
Mammalian Cell Culture ◽  
Therapeutic Monoclonal Antibodies

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.

Interaction of mammalian cell culture broth with adsorbents in expanded bed adsorption of monoclonal antibodies

1999 ◽  
Vol 34 (2) ◽  
pp. 159-165 ◽  
Author(s):  
J. Feuser ◽  
M. Halfar ◽  
D. Lütkemeyer ◽  
N. Ameskamp ◽  
M.-R. Kula ◽  
...  
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibodies ◽  
Mammalian Cell ◽  
Mammalian Cell Culture ◽  
Culture Broth ◽  
Expanded Bed Adsorption ◽  
Expanded Bed

scholarly journals Criteria for bioreactor comparison and operation standardisation during process development for mammalian cell culture

2011 ◽  
Vol 5 (Suppl 8) ◽  
pp. P47 ◽  
Author(s):  
Oscar Platas Barradas ◽  
Uwe Jandt ◽  
Linh Da Minh Phan ◽  
Mario Villanueva ◽  
Alexander Rath ◽  
...  
Keyword(s):  
Cell Culture ◽  
Mammalian Cell ◽  
Process Development ◽  
Mammalian Cell Culture

scholarly journals Mammalian Cell Culture Clarification: A Case Study Using Chimeric Anti-CEA Monoclonal Antibodies

2011 ◽  
Vol 12 (4) ◽  
Author(s):  
Mohamed Ali Abol Hassan ◽  
Abdul Wahab Mohammad ◽  
And Badarulhisam Abdul Rahman
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibodies ◽  
Host Cell ◽  
Cell Lines ◽  
Mammalian Cell ◽  
Mammalian Cells ◽  
Culture Media ◽  
Mammalian Cell Culture ◽  
Host Cell Proteins ◽  
Depth Filtration

The extracellular expression of monoclonal antibodies (mAbs) in mammalian cell culture provides both opportunities and restrictions for the design of robust harvest and clarification operations. With advances in cell culture media and cell lines, it is now possible to achieve high titers of over 5 g/l for mAbs. However, Mammalian cells are sensitive to breakage due to shear stress that can result in release of proteases and other host cell proteins (HCPs) which eventually affects product stability and purity. There is larger number of mAbs undergoing clinical development and it has placed significant importance on platform technologies of process development. Generally, Centrifugation and microfiltration are the primary harvest techniques used in the industry and depth filtration is also used as a step operation on clarification. This study compares the unit operations; centrifugation, microfiltration and depth filtration for maximum recovery of monoclonal antibodies. The results have shown that the depth filtration as more suitable operation for mammalian cell culture clarification since it gives 96% recovery of mAbs in comparison to centrifugation and microfiltration. ABSTRAK: Pengungkapan luar sel dari antibodi monoklon (monoclonal antibodies ((mAbs) dalam kultur sel mamalia memberi ruang dan batasan terhadap reka bentuk penuaian yang cekap dan penerangan operasi. Dengan kemajuan dalam media sel kultur dan cell lines (produk yang berupa sel kekal yang digunakan untuk tujuan kajian biologi), kini adalah berkemungkinan untuk memperolehi titer tinggi melebihi 5g/l untuk mAbs [2]. Walaupun begitu, sel mamalia sensitif terhadap retakan disebabkan tegasan ricih yang menyebabkan pengeluaran protease dan hos sel protein yang lain, (host cell proteins (HCPs)) akhirnya mempengaruhi kestabilan dan keaslian produk. Terdapat mAbs dalam jumlah besar yang masih menjalani pembangunan klinikal dan sesungguhnya ini penting sebagai satu landasan teknologi dalam proses pembangunan. Umumnya pengemparan dan mikropenurasan merupakan teknik asas tuaian dalam industri dan penurasan dalam juga digunakan sebagai satu pengendalian langkah dalam penjelasannya. Kajian ini membandingkan operasi unit: pengemparan, mikropenurasan dan penurasan dalam untuk perolehan antibodi monoklon yang maksima. Keputusan menunjukkan penurasan dalam adalah operasi yang lebih sesuai untuk penjelasan kultur sel mamalia kerana ia memberikan perolehan 96 % mAbs berbandingkan dengan cara pengemparan dan mikropenurasan.

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