GCCL Develops Biosimilar Trial Analysis, Enhances Custom Services

GCCL, a clinical trial sample analysis institution based in Yongin, South Korea, has made significant strides in the field of pharmacokinetic (PK) analysis for biosimilars. The company recently announced the development of PK analysis methods specifically for blockbuster drugs such as 'Keytruda' and 'Yervoy', marking a notable advancement in their tailored clinical trial analysis services for biosimilar development.

Earlier this year, GCCL established a new research and development (R&D) division. This new division focuses on the research and development of biomarkers, as well as the creation and validation of advanced analysis methods. The emergence of diverse and sophisticated analysis methods required in clinical trials has prompted the need for specialized R&D services. This division was established to meet the growing demand for innovative analysis methods and validation processes.

GCCL has zeroed in on biosimilars as the primary focus of its new R&D activities. One of their key projects has involved the development and validation of PK analysis methods for major drugs nearing patent expiration. By doing so, GCCL aims to assist biosimilar developers in swiftly conducting clinical trial analysis to compare PK equivalence without incurring significant time and cost in developing new analysis methods. Among the blockbuster drugs for which PK analysis methods have already been developed are 'Keytruda' and 'Yervoy', both of which are anticipated to face intense competition as their patents expire.

In addition to these efforts, GCCL is also engaged in the research and development of analysis methods for various other drugs, such as the breast cancer treatment 'Perjeta'. To support these initiatives, the company employs a range of sophisticated equipment, including ELISA and ddPCR.

GCCL has further expanded its capabilities by being the first in the industry to introduce ddPCR equipment for the enhancement of clinical trial analysis, particularly for cell and gene therapies. This state-of-the-art equipment allows GCCL to provide advanced clinical analysis solutions that align with the latest trends in clinical trial development. The R&D division leverages ddPCR technology to develop and validate analysis methods for biopharmaceuticals and biomarkers, thereby expanding its service offerings.

Yang Song-hyun, CEO of GCCL, emphasized the significance of these advancements, stating, “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.” He further expressed a commitment to continuing the enhancement of clinical sample analysis services and R&D capabilities. This commitment is in line with the evolving trends in pharmaceutical development, and it aims to establish GCCL's competitive edge in the market.

GCCL stands out as a Good Clinical Laboratory Practice (GCLP)-certified agency accredited by the Ministry of Food and Drug Safety of South Korea. The company offers comprehensive clinical trial sample analysis services that span all phases of clinical trials, from phase 1 through phase 4. With its variety of analysis platforms that adhere to global quality standards and its proprietary sample logistics system, GCCL serves partners across Asia and beyond, ensuring high-quality and reliable clinical trial sample analysis services.