Search results for " variability"
Article
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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Article
Risk Assessment: Studying Chromatography Resin Variability
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Many factors can give rise to process variability, such as variation in different process parameters or raw materials. This article focuses on process robu…
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.
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
Using Quality by Design to Develop Robust Chromatographic Methods
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The quality-by-design principles that enable a manufacturer to limit and control the sources of process variability are equally important to measurement systems, because the variability in …
Article
Assessing Manufacturing Process Robustness
It focuses on the evaluation of intra- and inter-batch variability, and can be applied to both large- and small-molecule pharmaceuticals (9). This review process involves comprehensive process assessm…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Starting material variability
The raw materials for allogeneic cell therapies cannot be manufactured on demand, but instead, rely on a network of volunteer donors. This creates variability in cell…
Article
Use of Multivariate Data Analysis in Bioprocessing
They demonstrate the potential of MVDA to become an integral part of upstream process control by effectively eliminating the major sources of variability, thereby leading to significant improvement in…
Article
Improving PAT for Biologics
Implementing PAT for bioprocesses presents unique challenges given the greater complexity of cell-culture and fermentation processes, the variability of raw materials (particularly living organisms), …