- Newly established R&D division this year is expected to
provide full-scale in-house R&D in addition to clinical sample
analysis
- Including blockbuster drugs such as 'Keytruda' and 'Yervoy',
GCCL offers tailored clinical trial analysis services for
biosimilar development
YONGIN, South Korea, July 16,
2024 /PRNewswire/ -- GCCL, a clinical trial sample
analysis institution, has proactively
developed pharmacokinetic (PK) analysis methods for
blockbuster drugs' biosimilars and offers customized clinical trial
analysis services for biosimilar development.
GCCL has established a new R&D division this year. The newly
established R&D division specializes in the research and
development of biomarkers, analysis methods, and validation. As
analysis methods required for clinical trials diversify and become
more advanced, the department provides R&D services to meet the
increasing demand for new analysis method development and
validation.
GCCL has focused on biosimilars as the first specialized area of
its R&D division, undertaking the development and validation of
PK analysis methods for blockbuster drugs to support biosimilar
development. Initially, GCCL has completed the development of PK
analysis methods for blockbuster drugs such as 'Keytruda' and
'Yervoy'. As these drugs approach patent expiration, competition
for development is expected to be fierce. Aligning with recent
trend, GCCL aims to proactively develop and validate the necessary
analysis methods for developers, enabling swift clinical trial
analysis to compare PK equivalence of biosimilars without time and
cost expenditure on developing analysis methods. Moreover, GCCL is
conducting R&D on various analysis methods, including those for
the breast cancer treatment 'Perjeta', using equipment such as
'ELISA' and ddPCR.
Furthermore, GCCL recently introduced ddPCR equipment for the
first time in the industry to enhance clinical trial analysis for
cell and gene therapies, providing advanced clinical analysis
solutions based on the latest clinical trial development trends.
The R&D division also utilizes the newly introduced ddPCR
equipment to develop and validate analysis methods for
biopharmaceuticals and biomarkers.
CEO Yang Song-hyun of GCCL
stated, "The news of completing the development of analysis methods
for biosimilar PK analysis of blockbuster drugs shortly after the
establishment of the R&D division is another testament to
GCCL's expertise," adding, "We will continue to enhance our
clinical sample analysis services and R&D capabilities for
various therapeutics such as biosimilars, ADCs, and CGTs, in line
with recent pharmaceutical development trends, to showcase GCCL's
unique competitive edge."
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.
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content:https://www.prnewswire.com/news-releases/gccl-completes-proactive-development-of-biosimilar-clinical-trial-analysis-methods-providing-customized-analysis-services-through-enhanced-rd-capabilities-302198836.html
SOURCE GCCL