2024. 07. 17

[PR] GCCL Completes Proactive Development of Biosimilar Clinical Trial Analysis Methods, Provi

- 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 developmentGCCL, 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.Source : GCCL Completes Proactive Development of Biosimilar Clinical Trial Analysis Methods, Providing Customized Analysis Services through Enhanced R&D Capabilities (prnewswire.com)

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