NKCL Bio Group Inc. The manufacturer of the NK Cell 1-person automatic incubator, has obtained CE/KC certification.

NKCL 2023.08.01 09:51 조회 1884


NKCL Bio Group announced on the 31st that it has obtained both CE certification and KC certification on the 27th for ‘RK-NKTM ACS (hereinafter referred to as ACS-I)’, an automatic single-person NK cell cultivator released this year.


CE certification is an integrated standard certification mark meaning that it meets all the requirements of the European Union (EU) in relation to safety, health, environment and consumer protection, and KC certification is the Korean Ministry of Knowledge Economy, Ministry of Labor, Ministry of Environment, Korea Communications Commission, It means safety, health, environment, and quality certification mark unified and standardized by five ministries including the National Emergency Management Agency.


As a result, NKCL can comply with the manufacturer's Declaration of Conformity in order to enter the global market as well as the domestic market, and eliminate various quality safety problems that may occur when exporting overseas.


In the meantime, NKCL Bio Group has laid the foundation for global advancement by acquiring a total of 3 overseas patent registrations in the US, Japan, and China in addition to 10 domestic patents. In addition, it has built up unrivaled technology in the field of NK cell therapy, such as the recent completion of its second Japanese patent registration. In addition, 13 domestic patents and 9 overseas patents are pending.

An official from NKCL Bio Group said, “We have the original technology for culturing NK cells as well as the technology that can secure a high yield of more than 10 billion cells in culture.” ” he said. In addition, he added, “We have started phase 1 and 2 clinical trials for various cancers this year and are seeing more than expected effects.”


ACS-I is a system that fully automates the entire process of NK cell culture, and it can show the highest culture success rate at each culture stage by monitoring the automatic culture system and artificial intelligence (AI) algorithm using robotics. In addition, it has the feature of being able to create target cells that fit the patient's body through 14-day culture through single-use and disposable culture.


An official from NKCL Bio Group said, “I am happy that the results of various efforts that have been devoted to R&D are starting to come out one by one.” “We will do our best to further increase the size of the NK cell market this year.”


NKCL Bio Group expects that the release of ACS-I will open the door to its first bio sales as a bio company.


[Source] Medical Today