Vironova has received the world’s first and only GMP certification for Electron Microscope Lab from Swedish Medical Products Agency
(Stockholm, Feb 7, 2020) – Vironova AB (publ), the pioneer in empowering new biopharma drug development and quality control by using advanced electron microscopy, has received a certificate of GMP compliance of a manufacturer from the Swedish Medical Products Agency (Läkemedelsverket).
Good manufacturing practices (GMP) are formal regulations put in place by regulatory bodies around the world, and GMP applies for customers within the pharmaceutical industry involved in developing and manufacturing of investigational medicinal products (IMP) and licensed medicinal products. The standards are designed to minimize the risks that cannot be eliminated through testing the final products.
GMP labs are used for many purposes- supporting translational research projects, participating in clinical trials, ramping up commercialization, optimization of assays to promote process improvement and measurement, etc.
As claimed by the Swedish Medical Products Agency, Vironova enable “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 and cryogenic Transmission Electron Microscopy with semi-automatic particle detection and analysis using software.”
“Customers are excited and impressed with our highly-developed laboratories and well-trained experts. Our clients benefit through the preparation of accurate and reproducible image datasets; the generation of reliable quantitative data; and the robust conclusions from the analysis. Good Manufacturing Practices are central to our commitment to our customers, as well as our promise to uphold quality, dependability, control, accuracy, and safety in every EM service we perform.” said Dr. Josefina Nilsson, Head of EM Services.
” It’s a big milestone for electron microscopy as well. From now on, electron microscopy is one of the most advanced analytical instruments used in the Pharmaceutical industry. It goes without saying that Vironova is the only player to offer this solution to Pharmaceutical companies working in the promising fields of Gene Therapy, Vaccines, and Drug Delivery.” added by Mohammed Homman, CEO of Vironova.
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.