Published DATE: May 20th, 2022
NEXEL, a global leader in human induced pluripotent stem cell (hiPSC) technology, recently announced that it has achieved the certification for So-Bu-Jang specialization by the Korea Evaluation Institute of Industrial Technology (KEIT). KEIT is a government-affiliated institute under the South Korean Ministry of Trade, Industry, and Energy.
This Korean word ‘So-Bu-Jang’ comes from the first syllables of the three words 소재; Sojae (Material), 부품; Bupoom (Components) & 장비; Jangbi (Equipment). So-Bu-Jang certification policy is a system that certifies companies that develop and manufacture materials, components, or equipment technology to enhance technological competitiveness in the global market. NEXEL’s strong technological base in hiPSCs with high genome stability and pluripotency led to this achievement. With this certification, NEXEL will be able to receive overall support for commercialization, management support, and technical support from the KEIT.
NEXEL is currently leading the high-tech industry with specialized technology in the hiPSC field. With this hiPSC as the main Sojae (Material), NEXEL produces various kinds of cells, including the most well-known Cardiosight®-S, satisfying 13 kinds of strict quality control categories such as functionality, purity, and viability. As the application of the revised ICH Guidelines (S7B/E14) is imminent in the U.S. FDA, EU, and ICH member countries, the demand for hiPSC-derived cardiomyocytes, such as NEXEL’s Cardiosight®-S, is expected to increase starting with the EU's application in August.
CEO Han said, "It is rare for biotechnology companies to obtain this Sobujang certificate. This is an acknowledgement that NEXEL possesses the expertise not only as a company with a clinical treatment pipeline but also as a company with differentiation in advanced technology”.