Search results for " variability"
Article
Optimizing your Cell Culture Process to Improve Productivity
Variability occurs when a biological is involved, however, it is important to understand the ranges of optimal performance which helps put boundaries on variability. It could also be used to analyze m…
Article
Using Digital Twins to Model Process Chromatography
…amics and develop a design space that will function with simple controls even in the face of process variability.
The challenges in implementing model-based control strategies are the availabilit…
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Cell-free Expression Systems Pose Cell Culture Alternative
The professors explain that protein therapeutics (biologics) produced by cell culture face limitations, such as high product variability created by glycoform (micro- and macro-) heterogeneity; difficu…
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Updating Viral Clearance for New Biologic Modalities
After all, he reasons, how can you say you’ve removed something from a process when its presence may be unknown, and its nature unpredictable?
In addition, there is great variability between virus…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
“This challenge is more likely to apply to drug substance rather than drug product because drug substance processes typically have significantly more variability between different products,” Shave not…
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Technology Innovations Improve Process Chromatography Performance
He adds that variability in raw materials can present serious issues that impact downstream efficiency and can lead to long investigations and potential delays in making drugs available for patients. …
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Flexible Facilities for Viral Vector Manufacturing
“There is quite a bit of variability when it comes to viral vector manufacturing scales. It depends on the use of the vector (i.e., is it used as a reagent, as in the case of gene modified cell therap…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
With a scale-out rather than scale-up approach to meeting production requirements, there is a greater risk of variability in process conditions and product quality between individual bioreactors. Bior…
Article
Moving PAT from Concept to Reality
“Regulators expect process monitoring and controls based on the entire batch data and the ability to revise controls to compensate for raw material variability or the use of different batches of raw m…
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Cytiva Announces Digital Collaboration with Amgen To Improve Biomanufacturing Performance Reliability
Cytiva announced a digital data exchange collaboration program with Amgen, which will include advanced data analytics to increase the understanding of the relationship between raw material variability…