- Introduced the first ddPCR device in Korea to provide
high-quality clinical trial sample analysis services by increasing
test accuracy
- Differentiate global lab services for cell and gene therapy
clinical trials with cutting-edge technology
YONGIN, South Korea, May 22, 2024
/PRNewswire/ -- GCCL, a Korean clinical trial sample analysis
company, has introduced Droplet Digital PCR devices (ddPCR) for the
first time in the domestic clinical trial sample analysis industry,
enhancing its capabilities in analyzing samples for cell and gene
therapy clinical trials.
Currently, real-time PCR analysis is widespread in the field of
clinical trial sample analysis for cell and gene therapy. However,
the existing analysis methods have limitations such as relying on
calibration reference standard samples for relative quantification,
low analysis efficiency due to manual labor, and the necessity of
separate analyses.
GCCL solves the existing problems by implementing automated
ddPCR-based analysis. The newly introduced ddPCR device from
Bio-Rad's QX ONE Droplet Digital PCR, utilizes a different
operating principle than conventional real-time PCR, enabling
absolute quantitative analysis without the need for calibration
standards. Moreover, stable PCR reactions allow detection in
low-concentration samples and the automated devices have a very low
rate of human error that could occur with manual labor.
Notably, GCCL is a leader in its field as it has the first
clinical trial sample analysis experience for CAR-T therapy in
Korea. Based on this, GCCL plans to provide ddPCR-based clinical
trial sample analysis services through its newly established
R&D unit.
GCCL's Director of Operations for the Lab Operations division,
Hee Joo Lee, mentioned, "The first
implementation of the automated ddPCR device in the clinical trial
sample analysis field will enable faster and more accurate results
to help advance the success of cell and gene therapy drug
development." Furthermore, she added, "With the introduction of
this device, GCCL has secured competitiveness not only in the
domestic but also in the global market." Lee concluded, "GCCL will
position itself as a global central lab by providing superior
clinical sample analysis for advanced biopharmaceuticals including
cell and gene therapies, with ongoing investment and proven
expertise in oncology, central nervous system (CNS) disorders,
infectious disease, and in other various areas."
About GCCL
GCCL, a Good Clinical Laboratory Practice (GCLP)-certified
agency accredited by the Ministry of Food and Drug Safety of
South Korea, is a clinical trial
sample analysis company that provides services for all phases of
clinical trials from phase 1 to 4. Based on its variety of analysis
platforms that meet global quality standards and its own sample
logistics system, the company is providing clinical trial sample
analysis services for its partners across Asia and beyond.
This press release may contain forward-looking statements,
which express the current beliefs and expectations of GCCL's
management. Such statements do not represent any guarantee by GCCL
or its management of future performance and involve known and
unknown risks, uncertainties and other factors. GCCL undertakes no
obligation to update or revise any forward-looking statement
contained in this press release or any other forward-looking
statements it may make, except as required by law or stock exchange
rule.
GC & GCCL Contacts (Media)
Rachel Kim
rachel.kim@gccorp.com
HyeYeon Woo
hywoo@gccorp.com
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SOURCE GCCL