Search results for " process variability"
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
Quality by Design in Biotherapeutics Purification: Understanding and Addressing Sources of Process Variability
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The principles and methodologies of biopharmaceutical manufacturing are well established today. However, the increased molecular diversity br…
Article
Raw Material Variability: The Need for Deeper Process Understanding
Principles and methodologies for biopharmaceutical development and manufacturing are well established today. However, the increased molecular diversity and drive for higher productivity brings new c…
Article
Scale-Up Model of a mAb Process from Microbioreactor to XDR-1000
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In process development, it is desirable to test process parameters in small scale and later scale up the process into larger production scale. A theoretical scale-up study was per…
Article
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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Resource
A Route to Deeper Process Understanding—Studying Resin Variability Using a Process Characterization Kit
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Resource
Studying Resin Variability Using a Process Characterization Kit: A Route to Deeper Process Understanding
https://info.cytivalifesciences.com/QbD-webinar-register.html
Article
Considerations for Improving Outcome in Biopharmaceutical Process Development
In this article, we take a look at how the process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different stra…
Webcast
Controlling Cell-Culture Process Variability
Impurities in raw materials are a risk to your cell productivity and protein quality. That is why we created a transparent, multi-source supplier network for cell-culture materials.
Article
Understanding Validation and Technical Transfer, Part 3
…e demonstrates how some conventional validation approaches may not be applicable due to the inherent process variability and because of the low numbers of units produced.
In this example, the …