Press release -
Best practices from Vironova Biosafety in new publication
Vironova Biosafety specialize in viral clearance studies for biological drugs. These kinds of drug products based on live cells have an inherent risk for viral contamination that could cause serious harm or death to patients.
Vironova Biosafety’s work is a critical part of a drug license holder’s application for regulatory approval in which it must demonstrate that a manufacturing process can remove or inactivate viral contaminants.
This week an article entitled “Putting viral clearance capabilities to the test” was published on Biopharm International (see link to article) with contributions by Gustav Gilljam, client project manager at Vironova Biosafety. He describes the key elements to planning a virus clearance validation and the article as a whole, with contributions from several experts, gives a thorough overview of the scope and challenges of this work.
Related links
Topics
- Medical research
Categories
- vironova
- biosafety
Vironova is a Swedish biotechnology company providing comprehensive, hardware, software and services for the analysis of nanoparticles. Vironova revolutionizes access to transmission electron microscopy (TEM)-based image analysis in biopharmaceutical development. Our solution enables automated analyses for faster and better-informed decisions to secure robust bioprocessing and final product quality.
The Vironova offering comprises:
- Cost effective, fast Electron Microscopy (EM) services enabled by the in-house developed Vironova Analyzing Software (VAS) designed for semi-automated nanoparticle analysis
- Viral clearance testing performed in GLP and BSLIII certified laboratories
- MiniTEM™, a bench-top Transmission Electron Microscope system designed for automated nanoparticle characterization. High-resolution images reveal particle morphologies that are transformed into accurate metrics.
