NKCL Bio Group (hereinafter referred to as NKCL) announced that it has successfully developed a multi-person (currently up to 16-person) NK cell automated incubator ‘RK-NKTM ACS-II (hereinafter referred to as ACS-II)’ in just two years since launching the single-person NK cell automated incubator ‘RK-NKTM ACS-I’ in 2023.

NKCL Chairman Shin Dong-hwa announced, “We have succeeded in developing a strategy to enhance the NK cell single-user automatic incubator based on a fully automated system,” and added that the existing single-user, disposable-based system can be modularized to expand productivity to accommodate 2-user, 4-user, 6-user, 9-user, and up to 16-user systems to meet the needs of users.

This achievement goes beyond simple system advancement. Currently, all cell culture devices developed domestically and internationally are limited to single-serving cells. However, NKCL's ACS-II can simultaneously produce cells for up to 16 people with a single device. Whereas previously 100 automated incubator systems were required to produce 100 doses per day, the ACS-II now requires only six to ten automated incubator systems.

This is a very positive sign for the cell therapy production process. Not only does it improve space efficiency, it is also expected to become a groundbreaking system model for the CDMO industry. NKCL announced plans to fully enter the bio-materials and components market. Bio-materials and components refer to the production equipment and disposable consumables used in the biopharmaceutical contract development and manufacturing (CDMO) process. Specifically, these include cell culture media (bioreactors), disposable bags (single-use bags), and media (media). As biologically based therapeutics, biopharmaceuticals have a complex manufacturing process and are sensitive to contamination, necessitating advanced equipment.

ACS-II was developed as a fully "closed system," minimizing the risk of contamination and facilitating improved quality control in compliance with GMP regulations. A closed system, a term used in cell therapy manufacturing, refers to a closed culture system that minimizes or completely blocks contact with the external environment. This system is essential for CDMOs to meet the GMP regulations mandated by the Ministry of Food and Drug Safety.

With the recent development of the CDMO industry, the role of the small business owner (SBO) has become increasingly important. As many global biopharmaceutical companies automate their production processes, the market for automated equipment for these bio SBOs is growing.

Through the development of the ACS-II, NKCL has automated the cell manufacturing process and achieved mass production capabilities. This will provide a groundbreaking solution to the cell therapy manufacturing process, which has been highly reliant on research personnel and has shown limitations in producing consistent quality. NKCL aims to launch a prototype within the year, first introducing it to its GMP facility at its headquarters in Dongtan, and then expanding into overseas markets next year. Furthermore, the company is also developing equipment for blood separation and cell collection processes.

As a company possessing the core technology for developing cell therapy products, NKCL stands out from existing small and medium-sized enterprises (SMEs) that simply develop equipment. This is because they can accurately identify and realistically reflect the needs of R&D and biopharmaceutical production sites. 

An NKCL representative stated, "With the development of the ACS-II, we anticipate contributing to the domestic production of bio SMEs and accelerating our entry into the global market next year."