Baizensel "Obtains GMP Certification for In Vitro Diagnostic Medical Devices"

Kim Taegyu, CEO of VigenCell.

[Asia Economy Reporter Lee Gwanju] Baizencell, a company specializing in immune cell therapy, announced on the 6th that it has obtained certification for compliance with Good Manufacturing Practice (GMP) for in vitro diagnostic medical devices.

In vitro diagnostic medical device GMP is a management and quality assurance system by the Ministry of Food and Drug Safety that guarantees whether in vitro diagnostic medical devices can be consistently produced with safety, efficacy, and quality suitable for their intended use. Baizencell obtained GMP compliance certification in the 'Devices for Molecular Diagnostics' category, laying the foundation for its ongoing precision medical diagnostics business.

Through this GMP certification, Baizencell plans to sequentially realize research and development plans for tumor precision molecular diagnostic products capable of monitoring progress after immunotherapy, including the 'Cancer Gene-Related Test Product Group,' the 'Disease Diagnostic Tissue Compatibility Gene Test Product Group' using tissue compatibility gene testing, the 'Pharmacogenomics Test Product Group,' and the 'High-Risk Infectious Agent Gene Test Product Group.'

Kim Taegyu, CEO of Baizencell, said, "Since the completion of the GMP facility this year, we have been sequentially progressing with the originally planned tasks, including obtaining a license for manufacturing advanced biopharmaceuticals, producing clinical samples, and now obtaining GMP certification for in vitro diagnostic medical devices. We will continue research and development of immune system analysis diagnostic kits to realize precision personalized medicine."

Since completing the GMP center in April this year, Baizencell has been accelerating the acquisition of various GMP-related permits and licenses, including the license for manufacturing advanced biopharmaceuticals and production of clinical samples, as well as commercialization in related business fields.

This content was produced with the assistance of AI translation services.