Search results for " variability" in Articles / App Notes
Article
Biosimilar Quality Requirements
…nd later on purified through a variety of technologies, they will naturally have inherent lot-to-lot variability in their quality characteristics. Thus, it is important to sufficiently characterize t…
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Driving Improved Access to Biosimilars
But another company developing a biosimilar would be using a different cell line, posing potential risk because of the inherent variability in complexity for biosimilars, specifically in the drug subs…
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Biosimilars: Making the Switch Comes with Challenges
The issue of variability
A drive was initiated to reassure doctors and patients including a pharmacovigilance action programme to encourage reporting of adverse effects, communications with patien…
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The Lifecycle Change of Process Validation and Analytical Testing
To detect a small change in a process or a process drift, the underlying variability of the process when operating 'normally' must be understood. Automated algorithms can fail. Typically, this can occ…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
…uality-by-design and design-of-experiment techniques to address questions of optimization and reduce variability before implementing a drug substance/drug product sterile manufacturing regime,” state…
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Top Tips for Successful Development of Antibody Chromatography Processes
In this interview, Jakob Liderfelt, Product Manager at Cytiva, discusses main challenges faced during chromatography process development for mAbs and mAb variants such as fragments and bispecific a…
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Quality by design in biotherapeutics purification white paper
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 varia…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
Serum is used to inactivate the trypsin, but lot-to-lot variability and the instability of the serum may fluctuate the degree of trypsin inactivation, and thereby result in less control over the host-…
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Remote Monitoring and Big Data Advance Upstream Automation
Such innovations, Vann stresses, are critical to increasing digital maturity to the point where predictions can enable adaptation to inherent process variability so that consistent performance and qua…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
When it comes to raw material variability, process developers face a range of challenges as a result of molecular diversity and a need for higher productivity, such gaining a deeper understanding for …