Search results for " process control" in Articles / App Notes
Article
Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
In drug development and manufacturing, variability in raw materials presents high risks to the success of processes and products. When raw material variability issues arise, manufacturers and supplier…
Article
Challenge Analytical Complexity: Biacore™ SPR Systems for Candidate Selection, Characterization, and Quality Control
This webinar presents the utility of Biacore™ systems at all stages of the process, from selection of first candidates to clinical lead, as well as how to shorten and streamline the time to results …
Article
QbD and PAT in Upstream and Downstream Processing
For biological products, process control can be difficult to define and implement. O2 pressure, catalyst concentration, and pH are examples of critical parameters. It is important to note that mAbs ar…
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Continuous Manufacturing: A Changing Processing Paradigm
… of the fact that continuous manufacturing reduces manual handling of products and allows for better process control. An agency representative said at an International Forum and Exhibition on Process…
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Digitalization: The Route to Biopharma 4.0
A more common approach is to combine DCS with PLC/SCADA (18) to design a platform that can automate data pre-processing and analysis, reduce human intervention, automate process control, and perform f…
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Understanding Validation and Technical Transfer, Part 3
Once the process has been validated, routine process control records, measurements of critical process parameters, and CQAs will serve as a basis for deciding whether changes are necessary. Mult…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
For CPPs, a continuum of criticality allows for process control and monitoring strategies to focus where the greatest impact on product quality is achieved.
Quality risk management
Ri…
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Assessing Manufacturing Process Robustness
Part B is a diagnostic study of the current process control (a seven-step product assessment process) that results in determining the adequacy of the current control strategy.
Part A. Com…
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Being Thorough When Transferring Technology
Therefore, the process controls that were identified and demonstrated during process validation studies to maintain consistent and reproducible manufacturing processes and product critical quality att…
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The Lifecycle Change of Process Validation and Analytical Testing
In-line, continuous monitoring, and control systems, such as those associated with PAT, are helpful in maintaining and assuring process control. Assurance of process control can be obtained by observa…