Search results for " variability" in Articles / App Notes
Article
Raw Material Variability
The problem is variability. Variability is when an inconsistency creeps into the material, or some unforeseen change occurs that leads to an unexpected effect on the manufacturing process. It could be…
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What’s in your media? How costly is variability of cell culture media to your manufacturing process?
Today we are going to discuss what is your media and how costly variability of the cell culture media is to the manufacturing process. I am Megan Manzano, senior editor for BioPharm Interantional. Joi…
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Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
When raw material variability issues arise, manufacturers and suppliers must address them immediately by analyzing data, determining the root cause, and minimizing the variability. Variability can be …
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Differences in a drug that go beyond the range of variability in the reference product, particularly when they have clinical significance, are likely to be rejected as being a biosimilar by regulators…
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Quality by Design in Biotherapeutics Purification: Understanding and Addressing Sources of Process Variability
One of these challenges is how process developers might gain a deeper understanding for sources of variability and set mitigation strategies.
This white paper summarizes information around resin v…
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Raw Material Variability: The Need for Deeper Process Understanding
One of these challenges is how to get deeper understanding for sources of variability and set mitigation strategies.
This article shares some insights into how raw material variability is a pote…
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On-Demand Webinar: A Route to Deeper Process Understanding—Studying Resin Variability Using a Process Characterization Kit
This webinar illustrates a cation exchange chromatography process development workflow to assess the effect of ligand density variability on product quality and process performance using a Process Cha…
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The Evolution of Supply Chain Security: Increasing Focus on Raw Material Variability
An increase in the development of biological and patient-specific drugs has also reinforced the demand for heightened raw material control.
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Studying Resin Variability Using a Process Characterization Kit
Learn how Process Characterization Kits can be used to assess the potential impact of resin ligand density variability on product quality and process performance.
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Five Control Strategy Options to Prevent Resin Variability Impact
Here are the pros and cons of five control strategies that can provide process consistency even in the presence of chromatography resin variability.
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