Encell cracks the CAR-T production bottleneck, securing process technology that quadruples cell yield

[Financial News] Encell, a company specializing in contract development and manufacturing organization services for cell and gene therapies, has begun securing process technology that simultaneously improves cell yield and quality consistency, two of the biggest challenges in CAR-T therapy production. As the CAR-T market expands, production efficiency and process reproducibility are emerging as key factors in CDMO competitiveness, drawing attention to the move.
According to Encell on the 26th, the company has filed a patent for process optimization technology that improves cell expansion yield and quality during CAR-T therapy manufacturing.
The core of the technology is the precise control of T cell activation conditions and culture environments to minimize cell death and reduced proliferation. Internal validation showed that the final CAR-T cell yield increased more than fourfold compared with the existing process. The company said it also reduced donor-to-donor variation in cell quality, improving the reproducibility and stability needed for commercial production.
Not only output, but also cell characteristics improved. In CAR-T cells produced through the optimized process, the share of stem cell memory T cells (Tscm) and central memory T cells (Tcm), which have relatively higher in vivo persistence and durability, increased. The viral vector copy number (VCN) also met the U.S. Food and Drug Administration (FDA) guideline of fewer than five copies per cell.
CAR-T therapies differ in gene structures and vector characteristics from pipeline to pipeline, making it difficult to apply a uniform standard process. For that reason, the industry sees the ability to optimize production conditions for each client pipeline and repeatedly deliver consistent quality as a core competitive edge for CGT CDMOs.
One biopharmaceutical industry source said, "For CAR-T, process reproducibility is more important than simply having production facilities, because the key is to deliver consistent yield and quality even when the donor or pipeline changes." The source added, "If yield improvements and reduced quality variation continue through to actual commercial production, that could also become a positive factor in CDMO contract wins."
Meanwhile, Encell plans to expand its CDMO business into advanced CGT areas such as CAR-T based on this technology. In June, the company participated as a GMP validation specialist in a national R&D project led by the Ministry of Trade, Industry and Energy to develop a closed automated manufacturing system for cell and gene therapies.
The company plans to link its CAR-T process optimization capabilities with GMP validation expertise for closed and automated manufacturing systems, strengthening its ability to respond across the full cycle from process development to manufacturing and quality control.
An Encell official said, "We have secured process development capabilities that can improve productivity and quality at the same time, tailored to each client pipeline." The official added, "By combining customized process optimization with quality control technology, we will expand our competitiveness in the global CGT CDMO market."


[email protected] Kim Kyung-a Reporter