Search results for " variability" in Articles / App Notes
Article
Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Aseptic processing has garnered some increased scrutiny…
Article
Continuous Manufacturing: A Changing Processing Paradigm
points out that in continuous processing, sampling considerations will differ from batch; deviations might need to be handled differently; variability should be controlled; manufacturing changes manag…
Article
Application of Quality by Design to Viral Safety
Raw materials are selected with an understanding of their variability and how this variability will impact the manufacturing process. Risk analysis and scientific characterization identify those compo…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
• Predictive Bayesian Reliability (5) incorporates the CPPs, uncontrolled variables such as raw material and environmental conditions, inherent common cause variability, and variation due to unknown m…
Article
Elucidating Biosimilars Characterization
…yeast, or mammalian cells, and although these processes can be well-defined, they are subject to the variability inherent in living systems. The active ingredient for biologics can only be considered…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…
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…
Article
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…
Article
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…