Search results for " virus" in Articles / App Notes
Article
Flexible Facilities for Viral Vector Manufacturing
Single-use and modular systems will meet demand for rapid implementation at different scales.
By Jennifer Markarian
Industry experts have noted that there are limitations in the…
Article
Mapping a Route for Cell and Gene Therapy Process Development
On a big-picture level, the increased demand for viral-vector manufacturing services to support clinical trials for recombinant adeno-associated virus (rAAV)-based gene therapies has led to a shortage…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
Following the high interest in cell and gene therapies, there is a big interest in viral vectors, especially for adeno-associated virus, but also adenovirus. In 2019, a novel production process for ad…
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Moving PAT from Concept to Reality
As importantly, if contamination is caught sooner using in-process rapid testing for virus or microbes, contamination can be stopped before spreading downstream in the process, saving both money and t…
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Emerging Therapies Test Existing Bioanalytical Methods
FDA, Guidance for Industry: Design and Analysis of Shedding Studies for Virus of Bacteria-Based Gene Therapy and Oncolytic Products (Rockville, MD, August 2015).
7. S.A. Bustin et. al., Clin. Chem…
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Faster Flavivirus Vaccine Production
Surface Plasmon Resonance (SPR) analysis during process development provides data about virus behavior and host interactions. This is valuable both for regulatory compliance and future drug developmen…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
In addition, virus, microbe, and endotoxin monitoring and control continue to be crucial to assure product and patient safety, she said.
In attempting to determine the most important CQAs, the gro…
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Fundamentals of Viral Clearance Studies with a Focus on Chromatography
This article provides the basics of what you need to know when studying virus reduction of a chromatography step.
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Case Study: Process for Production of Oncolytic Adenovirus
The promising results from clinical studies on the use of viral vectors to address important medical needs have spurred interest in developing scalable and cost-efficient manufacturing processes. Here…
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Achieve Scalable Viral Vector Production
In our tutorial series on viral vector production, Cytiva scientists share their insights on virus production and how to tackle viral vector manufacturing challenges. In this episode, a scalable produ…