Search results for " process control" in Articles / App Notes
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The statement “all five PPQ lots pass CQA acceptance criteria” has no statistical meaning in determining the amount of risk the process control strategy has in producing future successful lots. A stat…
Article
Leveraging Data for Better Biopharmaceutical Process Control
BioPharm: In general, what progress are you seeing in the use of advanced process control and the use of predictive models?
Menezes: We see a significant change in how advanced control practice…
Article
Monitoring and Control of Inline Dilution Processes
Buffer management has received less attention in process intensification despite the high costs and labor-, space-, time-, and material-intensive nature of this common downstream activity.
By…
Article
Bioburden Control in the Biopharmaceutical Industry
The application of statistical process control (SPC) will be important in such instances to spot areas of risk, defect, and/or improvement that require action(s) to be put in place.
Trending ch…
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QbD Improves Cell-Culture Process Control
QbD Improves Cell-Culture Process Control
A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.
By Feliza Mirasol
Mar…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth.
Jan 01, 2015
By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…
Article
Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Biopharmaceutical manufacturers thus face a huge hurdle in bringing more advanced manufacturing and process control methods to the manufacture of cell and gene therapies. “New approaches will be neede…
Article
Process Development and Control for New Modalities
Increasing molecular diversity leads to more challenges in process development and control. Advancements in technology for manufacturing and online analytical monitoring have not caught up…
Article
Five Control Strategy Options to Prevent Resin Variability Impact
Control strategies that assure product quality and process performance are essential in biomanufacturing. Here are the pros and cons of five control strategies that can provide process consist…