Search results for " system"
Article
Avoiding Investigational Failures and Discrepancies
Even industry leaders have found themselves suffering from “death by CAPA” after cramming every quality event that occurs into their CAPA systems. It is becoming more evident that the key to effective…
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
…ances in bioreactor technology, media, buffers, and cell lines that produce higher titers in smaller systems—reflected an evolution in technology. Other product introductions included new chromatogra…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
This article proposes integrated solutions for systemic and proactive viral risk mitigation.
By Mark Plavsic
Use of continuous cell lines in the manufacture of biological therapeutic products, …
Article
Platform Approach Speeds Process Development
The platform includes vector design, cell line engineering, high-throughput screening by automation, systematic design of experiment (DoE)-based approaches for media and cell-culture process developme…
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Improving PAT for Biologics
Advances in high-throughput systems, Raman and near-infrared (NIR) spectroscopy, high-performance single-use sensors, and chemometric methods are also helping manufacturers of biopharmaceuticals overc…
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
Using Digital Twins to Model Process Chromatography
With a mechanistic approach, relatively sparse experimental data are used to describe the full dynamics of the system at hand, using deceptively simple fundamental natural laws from the fields of flui…
Article
Best Practices for Selecting a Top-Quality Cell Line
“Equally important,” stresses Fisch, “is the quality of the recombinant DNA expression and transfection systems. Incorporating recombinant DNA stably into a cell line’s genome in a manner that promote…
Article
Challenges in Cell Harvesting Prompt Enhancements
…separation, and fluid handling, addressed the problem by developing a modern cell-culture harvesting system, Culturefuge 100. The system uses a hollow spindle technology that provides a method of con…
Article
Platform Technologies Improve Protein Expression
… manufacturing, and the fact that complex non-natural proteins are not well-expressed in the current systems such as Chinese hamster ovary (CHO) cell lines, according to Mueller-Tiemann.
Improvin…