[Edaily Reporter Park Jung-Soo ] #ENCell Co., Ltd., a company specializing in contract development and manufacturing (CDMO) of cell and gene therapies, is showing strong gains. This is believed to be driven by buying interest following news that the company has filed a patent application for process optimization technology that significantly improves cell proliferation yield and quality during the manufacturing of chimeric antigen receptor T-cell (CAR-T) therapies.
According to MP Doctor on the 26th, as of 9:12 a.m., ENCell Co., Ltd. is trading at 6,050 won, up 3.07% (180 won) from the previous trading day.
This patent demonstrates ENCell Co., Ltd.’s technical capabilities in the CAR-T cell therapy field—which requires highly advanced process development—to optimize manufacturing processes according to the specific characteristics of each client’s pipeline. Amid the recent expansion of the immune cell therapy market—including natural killer (NK) cells—ENCell Co., Ltd. is enhancing its CDMO competitiveness by expanding its process development scope into the highly complex cell and gene therapy (CGT) sector, such as CAR-T.
For CAR-T cell therapies, the CAR gene construct and vector characteristics are designed differently for each pipeline; even when using the same CAR gene construct, the quality and immunological characteristics of the final cells can vary depending on the manufacturing process. Therefore, rather than applying a one-size-fits-all standard process, it is crucial to precisely optimize manufacturing conditions according to the characteristics of each pipeline.
In particular, during the initial T-cell isolation and activation stages, failure to properly control the intensity and exposure time of activation factors can lead to increased cell death, which may adversely affect subsequent proliferation yields and final product quality.
The technology for which ENCell Co., Ltd. has filed a patent application is a process optimization technology that improves these manufacturing limitations by precisely controlling T-cell activation conditions and the culture environment. It is designed to minimize cell death and reduced proliferation by finely adjusting the exposure conditions of activation factors at each process stage, thereby enabling the stable production of high-quality CAR-T cells.
ENCell Co., Ltd.’s in-house validation of this process demonstrated that the final CAR-T cell yield increased by more than fourfold compared to the existing process. Donor-to-donor variation in cell quality was also significantly reduced, confirming the process reproducibility and stability required for commercial-scale mass production.
The viral vector copy number (VCN), a key safety indicator, also met the U.S. Food and Drug Administration (FDA) recommended standard of less than 5 copies per cell. Notably, CAR-T cells produced via the optimized process showed a significant increase in the proportion of stem memory T cells (Tscm) and central memory T cells (Tcm), which are characterized by relatively low differentiation and high in vivo survival. Consequently, this is expected to have a positive impact on the persistence of CAR-T cells in the body and the maintenance of therapeutic efficacy during future clinical applications.
ENCell Co., Ltd. is also continuously strengthening its competitiveness in the manufacturing of CGTs, including CAR-T. The company is participating as a GMP validation specialist in the “Development and Validation of a Closed-Loop Automated Manufacturing System for Cell and Gene Therapy Products” project, which was selected last June as a national project under the Ministry of Trade, Industry and Energy’s “First 2026 R&D Project in the Biohealth Sector.”
Through this project, ENCell Co., Ltd. plans to advance its GMP validation technology to achieve the key elements of CGT manufacturing: closed-loop systems, automation, and standardization. The company’s strategy is to link its CAR-T process optimization technology with the validation technology for closed-loop automated manufacturing systems to enhance production efficiency and quality consistency for advanced biopharmaceuticals, including CAR-T, and to strengthen its end-to-end support system covering the entire lifecycle from process development to manufacturing and quality control.
An ENCell Co., Ltd. official stated, “This patent application for CAR-T process optimization technology demonstrates ENCell Co., Ltd.’s process development capabilities, which can simultaneously improve productivity and quality in line with the characteristics of our clients’ pipelines.” The official added, “Through a government-funded project by the Ministry of Trade, Industry and Energy, we are also advancing GMP validation technologies for CGT manufacturing infrastructure, thereby strengthening our CDMO competitiveness—which encompasses both process development and production—in the field of advanced biopharmaceuticals, including CAR-T.”
The representative continued, “Going beyond simple contract manufacturing, we will combine our customized process optimization know-how with our accumulated quality control expertise to provide total solutions optimized for each client’s pipeline,” adding, “Based on this, we will continue to expand our business competitiveness in the global cell and gene therapy CDMO market.”