Search results for " variability"
Article
Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.
By Mostafa Eissa
The biopharmaceutical industry has witn…
Article
Best Practices for Data Integrity
How might we leverage that data to minimize variability?’
At a large contract manufacturer in Salt Lake City, Utah, for example, one quality manager took it upon her team to try and ident…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
The basic requirement for a good model is for it to be predictive and be able to explain at least most of the variability in the data. In addition, the model should be feasible for implementation in a…
Article
Antibody Production in Microbial Hosts
The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.
By Anurag S. Rathore, Jyot…
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…