Imaging and quantifying the quality critical parameters of therapeutic nanoparticles in our proprietary FDA 21 CFR Part 11 compliant software.
The only GMP-certified TEM analysis service provider in the world with a BSL-II laboratory.
Supported the development of 25+ FDA-approved therapeutic nanoparticle products.
300+ years of combined scientific experience.
We are a quality control service provider for nanoparticles using TEM for the biopharmaceutical industry.
The only GMP-certified TEM analysis service provider in the world with a BSL-II laboratory and a proprietary AI-based software for imaging and analysis
For more than a decade, we are setting a high standard in quality control of therapeutic nanoparticles, always a step ahead of the trend.
We are now proud to introduce our newly developed method for determining the genome length of therapeutic nanoparticles. This powerful method can precisely measure the size (kb) of the genomic material packaged within individual therapeutic nanoparticles. We believe this method could fulfill the requirements of the regulatory authorities (FDA/EMA) by providing both full/empty ratio and exact genome length with just 3 µl of your product. Click the link below to know more about our new method.
Vironova BioAnalytics is the only GMP-certified Transmission Electron Microscopy (TEM) service provider worldwide, providing analytical support for therapeutic nanoparticle development in accordance with GMP and ICH guidelines.
We perform imaging and analysis at our BSL-II laboratory using our proprietary AI-based software that complies with FDA 21 CFR Part 11. Our software streamlines the analysis process, making the identification and characterization of particles more efficient, unbiased, and accurate.
We collaborate with our partners throughout the product development process, utilizing a TEM-based quantitative approach to determine quality parameters. With a decade of experience, we help our partners make informed decisions, add value, and ensure patient safety worldwide.
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