Search results for "virus" in Articles / App Notes
Article
Flexible Facilities for Viral Vector Manufacturing
There is less variability for lentivirus and gamma retrovirus that is used for virally genetically modified cell therapies (ex-vivo gene therapies); the scale is mostly 50 L and currently doesn’t go b…
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…
Article
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…
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…
Article
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…
Article
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…
Article
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…
Article
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.
Read more
Article
Case Study: Process for Production of Oncolytic Adenovirus
Here, we present a case study from a biomanufacturer developing a process for adenovirus oncolytic adenovirus production. The case study describes a process from upstream cell culture to downstream pu…
Article
Achieve Scalable Viral Vector Production
In this episode, a scalable production process for adenovirus is presented.