GC녹십자셀, 첨단바이오 의약품 제조기업 최초 인체세포등 관리업 허가 획득
‘인체세포등 관리업 허가’를 획득
*아래는 위 기사를 구글 번역기로 번역한 영문 기사의 [전문]이다. [Below is the [full text] of an English article translated from the above article with Google Translate.
GC Green Cross Cell, the first company to manufacture high-tech biopharmaceuticals, acquired permission for management business such as human cells
Acquired'Human Cell Management Business Permit'
[In the story of the case / Reporter Park Yeon-pa] = Cell therapy specialist GC Green Cross Cell (CEO Lee Yi-joo) announced on the 2nd that it has obtained the “human cell management business license” for the first time among high-tech biopharmaceutical manufacturing companies in Korea.
The permission for the management business of human cells, etc. was newly established as the'Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals' was enacted, and the relevant permission is required to collect, process, and supply human cells, etc., which are raw materials for advanced biopharmaceuticals. Do.
In other words, in the case of cell therapy products, the raw material must be extracted from the human body or other cells or tissues. Therefore, for consignment production of cell therapy products, a license for management business such as human cells must be obtained separately from the license for manufacturing high-tech biopharmaceuticals.
GC Green Cross Cell is able to produce cell therapy products fastest among domestic cell therapy product consignment development and production (CDMO) companies as it obtains permission for management business such as human cells.
Among the sales in 2020, CDMO sales such as Atiba Biotherapeutics and GC Green Cross Labcell in the US increased 524% year-on-year, and it plans to focus on sales profits by expanding the CDMO business in 2021.
GC Green Cross Cell CEO Lee Ik-ju said, “Through this permission for the management business of human cells, I think that we have gained an edge in the CDMO business, which is the fastest cell therapy product among domestic companies. In particular, the Cell Center is equipped with cGMP-level advanced facilities and production facilities that are optimized for cell therapy production, and is the largest cell therapy production facility in Korea that meets global standards by introducing advanced management and production systems.” .
CEO Lee Yik-joo said, “With the advent of CAR-T treatment, the CDMO field of cell therapy is attracting attention worldwide. GC Green Cross Cell is also using the know-how accumulated through licensing, production, and sales of cell therapy products. We are judged to be competitive enough.”
GC Green Cross Cell achieved sales of 35.6 billion won in Immuncell LC in 2020 and is developing CAR-T treatments for solid cancer.
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