Pharma Focus Asia

GCCL Enhances Gene/Cell Therapy Clinical Trials through ddPCR Technology

Thursday, May 23, 2024

GCCL, a pioneering Korean company specializing in clinical trial sample analysis, has introduced a groundbreaking advancement to the industry with the incorporation of Droplet Digital PCR devices (ddPCR). This marks a significant leap forward in the analysis of samples for cell and gene therapy clinical trials within the domestic market.

Traditionally, real-time PCR analysis has been prevalent in clinical trial sample analysis for cell and gene therapy. However, this method has been hindered by several limitations, including dependence on calibration reference standard samples for relative quantification, low efficiency due to manual processes, and the need for separate analyses.

GCCL addresses these challenges by implementing automated ddPCR-based analysis. The newly adopted ddPCR device, specifically Bio-Rad's QX ONE Droplet Digital PCR, operates on a distinct principle compared to conventional real-time PCR, enabling absolute quantitative analysis without the requirement for calibration standards. This technology also ensures stable PCR reactions, facilitating the detection of low-concentration samples, while the automated nature of the devices significantly reduces the potential for human error associated with manual labor.

Of particular note, GCCL holds a leading position in the industry, boasting the first-hand clinical trial sample analysis experience for CAR-T therapy in Korea. Leveraging this expertise, GCCL plans to offer ddPCR-based clinical trial sample analysis services through its newly established R&D unit.

Hee Joo Lee, Director of Operations for the Lab Operations division at GCCL, expressed excitement about the implications of this advancement. "The introduction of automated ddPCR devices in the clinical trial sample analysis field promises faster and more accurate results, thus propelling the success of drug development in cell and gene therapy," she stated. Lee emphasized that with this innovative addition, GCCL has not only strengthened its position in the domestic market but also established competitiveness on a global scale. She concluded by affirming GCCL's commitment to becoming a global central lab, offering superior clinical sample analysis for advanced biopharmaceuticals, including cell and gene therapies, through ongoing investment and demonstrated expertise across various therapeutic areas such as oncology, central nervous system (CNS) disorders, infectious diseases, and more.



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