Search results for " control"
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Single-Use Technologies Prove Effective for Viral Vector Process Development
Both, according to Cameau, offer more process control than flatware systems because bioreactors include sensors for monitoring of pH, dissolved oxygen (DO), carbon dioxide percentage, and other parame…
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Automating the Biomanufacturing Process
As a result, data integration is needed to handle the huge increase in product data from this growth to ensure that these raw data become information that can be used to control and improve the proces…
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Selecting a Comprehensive Bioburden Reduction Plan
…eduction?
Mittelman and Anicetti (PDA task force): The most important consideration in bioburden control is staff training at all levels within an organization. The planning process needs to invo…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
The 1X medium was used as a control. Feed media with concentrations of 1X, 1.30X, 1.60X, 1.75X, 1.90X, and 2.50X were prepared by adding 10 N NaOH to increase the pH and dissolve all of the components…
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The Lifecycle Change of Process Validation and Analytical Testing
…gh the implementation of process analytical testing (PAT) technologies to support the monitoring and control of product critical to quality attributes. I think material understanding throughout the m…
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Eliminating Residual Impurities Starts with a Strategic Plan
It also allows the development of an optimal process with a suitable control strategy and test methods in a timely fashion.
The implementation of a risk-based strategy for the testing of residua…
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Supply Chain Challenges for Single-Use Systems
The large number of raw materials makes forecasting demand more difficult and requires robust materials management, supplier quality management, quality control, and business continuity planning to en…
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Applying GMPs in Stages of Development
Areas to be reviewed to determine the appropriate level of control needed in concert with the phase development stage include: level of validation of test methods, level of detail needed in batch reco…
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Using Digital Twins to Model Process Chromatography
In this case, if a model describing the process is extant and describes the process when controlled, data for the out-of-spec chromatogram is fed back into the model. Process parameters are then chang…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Those process analytical technologies (PAT) are a critical part of control strategies that ensure continuous operation within the design space.
While …