Search results for " virus"
Article
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…
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Scaling Up Novel Therapies
Great improvements have been seen so far in delivering adeno-associated virus (AAV) vectors. These results demonstrate the inextricable link between clinical work and process development, said Kathy H…
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
• The downstream areas seen as needing the most improvements are now single-use purification, continuous downstream purification, and virus filtration. Again, desires for single-use technology took th…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
He cited a lack of capacity for manufacture of lentiviral and adeno-associated virus (AAV) vectors for limiting clinical development and noted that the process of production in current cell lines is n…