Search results for " control"
Article
Sterilization Trends for Single-Use Consumables
Three key trends: capacity, complexity, and process control
The increasing use of SU technologies for biologic drug manufacturing has led to the biggest recent trend related to sterilization of SU c…
Article
A Look into the Future of Biopharmaceutical Quality
Quality Control Unit Advancements
BioPharm: How do you see the role of the quality control (QC) unit changing in the coming years?
Newcombe (PAREXEL): I would not anticipate any significant…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
This resulted from the introduction of parental cell lines better suited to modern fed-batch processes and the development of better bioreactor processes, including control strategies for pH, carbon d…
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Automating Bioprocesses
The process control and automation requirements of SUS also differ from those of stainless-steel equipment. BioPharm International spoke with Michalle Adkins, director of Life Sciences Consulting, and…
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Improving Process-Scale Chromatography
Cytiva therefore offers several options to help improve data management, increase unit operation integration, and provide comprehensive control.
Implementation of single-use technologies
As fo…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
While one risk source may effectively be transferred outside, the internal focus then turns toward ensuring comprehensive controls are in place for ensuring vendor quality and continued supply.
Ri…
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Optimization of Protein Expression in Escherichia Coli
It carries the phage T7 gene 1—encoding T7 RNA polymerase—in its chromosome under the control of the lacUV5 promoter. Protein expression can be induced with the addition of isopropyl β-D-1-thiogalacto…
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Continuous Chromatography: Trends, Definitions and Approaches
Can you comment on the importance of process development and control in the continuous process?
Process development and control are the two very important aspects related to continuous chromatogra…
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Securing the Single-Use Supply Chain
In the past, when drugs were manufactured in stainless steel, the manufacturer was in control of the infrastructure once its facility was in place, sourcing only critical disposable components such as…
Article
Raw Material Variability
In this case, it might be extremely difficult to control variability due to environmental factors. Changing to a chemically defined material would be preferred but is not always possible for legacy pr…