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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. 

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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.

Press Conference

MIKROBIOMIK team for the validaiton of QUANTOM for microbial cell counting

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