Search results for " scaling" in Articles / App Notes
Article
Next Generation Process Chromatography
Chromatography is an essential part in the production of all biopharmaceuticals. Without it the industry would not be able to produce therapeutics in an economic manner. This is true for monoclonal …
Article
Manufacturing of Vaccines and Viral Vectors
In this article, general guidelines for scaling up a viral vector and virus manufacturing processes are discussed.
Article
Best Practices for Selecting a Top-Quality Cell Line
Before scaling up to bioreactors, the productivity level for monoclonal antibodies (mAbs) should be 2–7 g/L (fed-batch culture in shake flask) or greater, observes Selexis CEO Igor Fisch. Once scaled …
Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
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Achieving Process Balance with Perfusion Bioreactors
“When it comes to systems integration and control, cells are most happy in a steady state; control response, sensor accuracy, and so on can have an impact, and this is critical to keep in mind for sca…
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Multidimensional Scale-Up of a Monoclonal Antibody Capture Step, Using ÄKTA™ pilot 600
Column volume per hour (CV/h) was utilized to enable maintaining residence time throughout the scaling process. The process, performed with MabSelect™ PrismA Protein A chromatography resin, was scaled…
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Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
By Cynthia A. Challener
Single-use bioreactors available from various vendors…
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Generating a Fully Processed Antibody
The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
B…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
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