GICELL acquired a manufacturing license for advanced biopharmaceuticals and is selected as an eligible entity for the Smart Factory Construction and Advancement Project by the Ministry of SMEs and Startups.

- Recognized for its manufacturing base of advanced biopharmaceuticals by obtaining the manufacturing license

- Establishment of a smart factory crystallized with cutting-edge technology and quality advancement

GICELL’s GMP facilities (Photo provided by GICELL)

GICELL acquired a manufacturing license for advanced biopharmaceuticals x-x-from the Ministry of Food and Drug Safety.

The ‘Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ (Advanced Regenerative Bio Act), which took effect in August last year, stipulates that companies obtain a manufacturing license for advanced biopharmaceuticals to manufacture advanced biopharmaceuticals such as cell therapy products and gene therapy products.

GICELL's GMP(Good Manufacturing Practices for Good Manufacturing Practices), completed in June to manufacture advanced biopharmaceuticals, was built on a total area of 3,400m² and a total budget of 20 B KRW is planned to be invested in cell therapy products and protein production facilities. In particular, the facilities have been constructed so that allogeneic NK cell therapy (T.O.P. NK) applied with a ‘feeder free’ culture system without cancer-derived feeder cells can be cultured at the current level of 50L. This is the world's largest scale in the 'feeder free' method and plans to expand the scale to a maximum of 500L in the future to enable large-scale culture. This system is an innovative system that maximizes the safety and cost-effectiveness of NK cell therapy in a way that does not use cancer-derived feeder cells, which are commonly used to activate NK cells in the culture process. GICELL and Kiadis Pharma, which was acquired by global pharmaceutical company Sanofi, are representative of the companies possessing the ‘feeder free’ NK cell culture technology. The company plans to expand its manufacturing facilities for regulatory T cells and cytotoxic T lymphocyte.

In addition, the recombinant protein production line for ‘Ancillary Protein’, a unique culture material of GICELL, is also designed to produce up to 200L. The company plans to stride x-x-x-into the CDMO(contract development and manufacturing organizations) business for bio start-ups that develop protein and antibody drugs using the protein GMP facilities.

In the GMP facilities, employees with a substantial understanding of pipeline processes directly perform technology transfer and investigational product manufacturing. In addition, all products x-x-from ancillary proteins, the core of the immune cell platform, to various immune cell therapies under development are all manufactured independently. Therefore, the company has the advantage of manufacturing high-quality investigational products promptly instead of reaching out to a CMO(contract manufacturing organization) of cell therapy products that fiercely compete to secure slots.

Hyung Min Kim, Head of GMP, explained, “By obtaining this manufacturing license, our facilities have been proven to meet the requirements of the advanced GMP level in the manufacturing facilities, equipment, instrument, quality and operating systems to manufacture advanced biopharmaceuticals.”, and then continued, “Using these facilities, we can also manufacture immune cell-based commercial-grade pharmaceuticals, and as the first step, we will deliver high-quality samples for T.O.P. NK phase-1 clinical trial.”

The process of APV for 50L culture of NK cells using a bioreactor (Photo provided by GICELL)

Separately, GICELL was finally selected as an eligible entity for the '2021 Smart Factory Foundation and Advancement Project Phase II x-from the Smart Manufacturing Innovation Team of the Ministry of SMEs and Startups, after winning the 10:1 competition.

The Smart Manufacturing Innovation Team of the Ministry of SMEs and Startups supports capital expenditures to domestic small and medium-sized manufacturing companies depending on the availability of a smart factory and whether a security solution has been connected, if not established. Upon this selection, GICELL is to receive various forms of advanced support such as smart factory solution construction and automation equipment readied with advanced technology.

“The goal is to accelerate the development of GICELL’s excellent cell therapy products by using our recently-approved GMP facilities and to provide treatment options to suffering patients as soon as possible,” said Byeong-Cho Min, chief operating officer. Then, he remarked, “We will grow x-into the world's top-notch immune cell therapy company based on our world-class cell culture technology through our state-of-the-art smart factory facilities."

Link for press release (KR version): http://medipana.com/news/news_viewer.asp?NewsNum=290416&MainKind=A&NewsKind=5&vCount=12&vKind=1