We provide a complete GMP-certified TEM analysis package that includes both nsTEM and cryoTEM characterizations, each providing powerful image datasets, quantitative data, and conclusions from the analysis.
Everything in our lab has been built for the purpose of TEM analysis in a GMP-environment. Our TEM laboratory can be found at our headquarters in Stockholm, Sweden.
The testing performed to our client's sample follows strict internal protocols as specified in our client project management procedures. Depending on our client's requirements, the data provided by Vironova can be produced at different GMP levels. All project documentation is recorded and archived to ensure the process traceability, and all our critical equipment is calibrated and maintained.
Customer projects requiring GMP-certified facilities are:
In addition to a GMP-certified laboratory infrastructure, the test methods must be validated for its intended purpose.
We provide a possibility to validate your method of analysis through a validation study. Validating your method of analysis assures quality, reliability, and consistency of the result for the application of cryoTEM as an analytical procedure for a specific product.
GMP applies to the manufacturing process for both medicinal products and investigational medicinal products (IMP) to ensure quality control.
Our equipment is calibrated and maintained.
All visitors of our GMP-certified laboratory are required to be logged before entrance.
In 2020, Vironova received a GMP certificate from the Swedish Medical Products Agency. Quoting the agency, Vironova is able to do:
"Testing with the purpose of characterization, evaluation, quality assessment and quality control of particles in micro and nanometer scale (drug substances, intermediate drug substances, drug products) using negative stain Transmission Electron microscopy (nsTEM) and cryogenic Transmission Electron microscopy (cryoTEM) with semi-automatic particle detection and analysis using software".
Talos L120C is one of our transmission electron microscopes.