Search results for " process control"

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…

Article 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 New ReadyToProcess WAVE 25 Bioreactor Provides Advanced Control in Research, Process Development, and Manufacturing Operations
Next-generation WAVE Bioreactor™ from GE Healthcare Life Sciences provides state-of-the-art intelligent and accurate process control combined with true ease-of-use. When it was first …

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…

Poster Optimizing Process Control In WAVE Bioreactor™ 20/50 System
Disposable bioreactor technologies have been mainstream for over a decade, and like the traditional stainless-steel bioreactors, rapid progress has been achieved in the area of process control. This…

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