Microbial Cell Counter Validation with Mikrobiomik
Mikrobiomik is a biopharmaceutical company founded in 2018, based in Derio Technology Park (Vizcaya, Spain), being a pioneer in the country and Europe, promoting an innovative therapeutic approach based on the human microbiome to improve people's health and well-being.
Mikrobiomik has achieved a significant milestone by introducing the QUANTOM TX Microbial cell counter device and validating the method for counting total microorganisms as a quality control within the production process of the investigational biological medicine MBK-01.
In 2022, Mikrobiomik acquired the QUANTOM TX Microbial cell counter(Logos Biosystems, part of Aligned Genetics), from the local distribution company, Isogen Life Science (Netherlands). This device counts fluorescently stained cells by automatically acquiring images of the light emitted by the stained cells and provides objective counts of the cells detected in the images.
In 2023, experts from the Quality Control Department, with the assistance of the Quality Assurance Manager, have carried out the fine-tuning and subsequent development and validation of the method, following the ICH standards (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), to maintain the high standards required to produce under GMP regulations.
