09/09/24
As a disruptive and pioneering company, Mikrobiomik has achieved a significant milestone by introducing the QUANTOM TxTM 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 TxTM 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. “We are extremely pleased that the QUANTOM TXTM Microbial cell counter TXTM has been successfully validated and incorporated in the production process of the biological medicine MBK-01 of Mikrobiomik”, said Neon Jung, CEO of Logos Biosystems Biosystems (the Aligned Genetics company). “This is a significant advancement as it allows us to meet the high standards required for GMP regulations.”
This validation represents added value, not only for Mikrobiomik, but also in the future for the pharmaceutical industry and other industries associated with microorganisms, as this application had not been carried out until now. For Mikrobiomik this development represents another step in the search for excellence in its processes, providing speed, effectiveness, and an extra level of innovation.
Full article:
isogen-lifescience.com/success-stories-report/a-new-validaiton-method-mikrobiomik
