Search results for " design" in Articles / App Notes
Article
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 …
Article
Updating Viral Clearance for New Biologic Modalities
Improvements in chromatographic separations designed to maximize HCP and impurity removal have often resulted in higher levels of viral clearance as well, he says, pointing to MilliporeSigma’s chromat…
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Eliminating Residual Impurities Starts with a Strategic Plan
The best solution to managing risk factors is to use quality by design (QbD) to classify them, applying tools such as Ishikawa fishbone diagrams or failure mode and effects analysis (FMEA), agrees Luc…
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Good Manufacturing Practices: Challenges with Compliance
When a company can design processes that consistently meet all product quality attributes, then this not only meets the base expectations provided in the GMP regulations, it is actively pursuing excel…
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On-Demand Webinar: A Route to Deeper Process Understanding—Studying Resin Variability Using a Process Characterization Kit
Chromatography resin attributes, such as ligand density, can affect critical quality attributes (CQAs) as well as process performance depending on the process design and the separation at hand.
…
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Single-Use for Downstream Chromatography: Benefit or Hindrance?
With a facility set up for single-use system operations, facility design can be simplified and can be executed in about half the time needed to build a traditional facility with reusable systems, Youn…
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Leveraging Computational Models of Glycosylation for Biopharma QA
Examples of statistical models of TGP glycosylation are design of experiment (DoE) surface response models (23) and partial least squares regression (33,34). Advantages of statistical models are that …
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An Analytical Approach to Biosimilar Drug Development
As a result, demand has increased for chromatography and mass spectrometry technology providers to design instrumentation, software informatics, and workflows to support protein analysis studies. In a…
Article
Scaling Up Novel Therapies
In addition, they permit some degree of facility design standardization, improving operational flexibility and capital savings, he says.
Developers are exploring how these platforms might…
Article
Making the Move to Continuous Chromatography
Continuous chromatography systems are designed to be loaded continuously, which is a useful approach when the purification step is connected to an upstream perfusion bioreactor. There are several diff…