Sep 09, 2024

QUANTOM Tx™ cited as key device used by the first GMP facility in Europe

FOR RELEASE (09 September 2024) – Mikrobiomik, a biopharmaceutical company based in Vizcaya, Spain, has received approval by the AEMPS (Spanish Agency for Medicines and Medical Devices), as the first GMP (Good Manufacturing Practice) facility in Europe.

Mikrobiomik cited the use of the QUANTOM Tx™ Microbial Cell Counter as a key part of the facility noting its use for validating the method for counting total microorganisms as a quality control within the production process of the investigational biological medicine MBK-01.

With the approval by the AEMPS as the first GMP facility in Europe, Mikrobiomik will produce intestinal microbiota-based medicines, at a pilot scale, exclusively dedicated to supplying medicines for ongoing clinical trials.

“We are extremely pleased that the QUANTOM TX™ Microbial cell counter 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/Aligned Genetics company. “This is a significant advancement as it allows us to meet the high standards required for GMP regulations.”

Mikrobiomik, founded in 2018, uses an innovative therapeutic approach based on the human microbiome. Its activity focuses on the research, development, and production of a new generation of biological medicines based on the intestinal microbiota, aimed at serious diseases without an effective therapeutic alternative.

Isogen Life Science (Netherlands), a Logos Biosystems/Aligned Genetics distributor, played an integral role in the acquisition, installation, and training of the QUANTOM Tx for Mikrobiomik researchers.

With no culturing required, the QUANTOM Tx™ Microbial Cell Counter is able to count bacteria in less than 30 seconds, while scanning up to 10 fields of view to produce accurate single bacterial cell counts. The advanced software can account for the varying shapes, sizes, and arrangements of different bacteria.

Logos Biosystems, part of Aligned Genetics, has a full pipeline of imaging equipment from automated cell counters, digital and high-content imaging systems, to tissue clearing systems. Learn more at www.logosbio.com.cn.