2024. 10. 22

Envisioning a Korean edition of 'Q-Square': GCCL Next celebrates its 5th anniversary

GCCL is the first 'clinical trial sample analysis organization' in Korea, often referred to as an 'analysis CRO'. It operates differently from the typical clinical trial contract research organizations (CROs) that most people are familiar with. A notable global example of an analytical CRO is 'QSquare (Q2 solutions, now IQVIA Lab)'. GCCL shares several similarities with QSquare, such as being formed through company mergers, and is positioning itself as the ‘Korean version of Qsquare’. Celebrating its 5th anniversary this year, GCCL posted its first profit last year, affirming the viability of its business model and operational success.

Over the next five years, GCCL plans to focus on going ‘global’, a goal that is clearly reflected in its mission. GCCL stands for ‘Global Clinical Central Lab,’ and the company’s primary objective is to capture a share of the clinical trial sample analysis market, which is currently dominated by global analytical CROs. Presently, about one-third of GCCL’s projects involve global clinical trials. In a recent interview with <THE BIO>, GCCL’s CEO, Yang Song-hyun, shares the company’s achievements over the past five and its future plans, emphasizing its role as an ‘All in One Lab for Clinical Trials in Asia’ catering to both Korean and international pharmaceutical and biotechnology companies.

◇Korea's first clinical trial sample analysis institution (GCLP): An all-in-one lab from early to late clinical trial stagesEstablished in August 2019, GCCL is a joint venture (JV) formed through a collaboration between GC Bioscience Lab (now GC Labs), GC Cell (formerly GC Lab Cell), and CRO C&R Research, which were Korea’s first commercial laboratories. GCCL is the first joint venture between a CRO and a laboratory in Korea and the country’s first clinical trial sample analysis institution.

"We founded GCCL to offer specialized clinical trial analysis services similar to GlobalLab," CEO Yang Song-hyun said. "With the implementation of the GCLP certification system in Korea in 2019, we aimed to establish a professional analysis institution that adheres to these standards. In 2020, we became the first institution in Korea to achieve GCLP (Good Clinical Laboratory Practice) certification."

“While the traditional CRO focuses on ‘project management’ and overseeing the entire clinical trial process, an analytical CRO like GCCL specializes in analyzing human-derived samples, such as blood and urine, collected during clinical trials,” Yang further explained.

GCCL operates as an all-in-one lab, providing services that span from early-stage clinical trial analysis to late-stage clinical trials within the same facility. The company offers sample analysis services based on client needs through its ‘Bio-Analytical Lab’ for early clinical trials and its ‘Central Lab’ for late-stage trials.“By offering all services from early- to late-stage clinical trials in a single location, we can reduce logistics costs and ensure optimal sample stability,” Yang emphasized. “Previously, most samples generated in Korea were sent abroad, often to places like Singapore, for analysis. However, with the establishment of GCCL, we have taken the lead in analyzing samples domestically, marking our first major milestone.”

Since its founding, GCCL has completed more than 1,000 projects, with around 27% of these being global clinical trial projects. Yang pointed out that the share of global projects is steadily increasing. "GCCL is the only company in Korea to implement solutions like Watson LIMS (Laboratory Information Management System) and ddPCR (Digital Droplet PCR, a high-precision genetic analysis technology) in compliance with global regulatory standards, setting the trend for clinical trial sample analysis in Korea," Yang further highlighted.

◇Global market entry strategy: ‘Success in customer-driven novel drug development’—aiming for investment attraction in 2025 and IPO in 2028In response to the growing demand for advanced analytical methods alongside the advancement of clinical trials in line with novel drug development trends, GCCL launched a specialized analysis method development and verification organization this year and introduced the ‘R&D Lab’ service. The R&D Lab has developed biosimilar analysis methods for drugs like Keytruda, Yervoy, and Perjeta, as well as a cell therapy analysis method using ddPCR technology. Additionally, Yang mentioned that the Global Business Development (GBD) team was also established this year, actively participating in international exhibitions and academic conferences, where it has achieved meaningful results.

“The most assured path for GCCL to enter the global market is through the success of our customers’ new drug development,” Yang stated. “If the projects entrusted to our company gain new drug approval from global regulatory authorities’ bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), we anticipate that the company will also secure a global portfolio.”

“Last year, GCCL was the only Korean company selected as one of the ‘Top 10 Bioanalytical Service Providers in APAC 2023’,” Yang further commented. “After entering the Asian analysis service market in 2025, our goal is to expand into advanced markets by 2028 through participation in multinational clinical trials and to achieve a smooth entry into the global market by 2030.”

According to an overseas research institute, the global analysis service market was valued at around KRW 10 trillion (approximately USD 7.3 billion) last year. The bioanalytical market is estimated to be over KRW 5 trillion, while the central lab market is valued at more than KRW 4 trillion. In comparison, the Korean analysis service market is worth about KRW 200-250 billion. As Korean pharmaceutical and biotechnology companies expand R&D efforts and conduct more clinical trials, the clinical trial sample analysis market is also expected to experience continued growth.

“GCCL is dedicated to offering fast and proactive, customer-centered services that cater to client needs, as reflected in the positive feedback from customers who have used Global Lab,” Yang emphasized. “By providing high-complexity analysis services typically offered by Global Lab at more affordable prices, in line with novel drug development trends, we are helping to reduce Korean customers’ reliance on overseas markets.”

Yang highlighted that GCCL’s parent company, GC Cell, specializes in cell-gene therapy (CGT), which positions the company to also target antibody-drug conjugate (ADC) clinical trial sample analysis, a sector currently receiving significant attention in the global biotech market. “The domestic ADC market is still in its early stages, and next year we expect to see ADC development companies beginning their clinical trials in earnest,” he further added. “GCCL plans to concentrate on the biosimilar and ADC clinical trial sample analysis markets.”

GCCL has experienced continuous growth since its inception, but this year it anticipates achieving sales figures similar to those of the previous year due to challenges in the Korean market situation, including the medical crisis. The company has also forecast a shift to an operating loss as a result of significant investments made to expand its service capabilities this year. “We are working to expand our global project order base to mitigate the impact of domestic market conditions, and we expect to see tangible results and stable revenue generation in two or three years,” Yang remarked. “Next year, we plan to seek investments during this crucial period. We are targeting an initial public offering (IPO) in 2028.”

Yang emphasized that GCCL’s objective is to become the leading Korean clinical trial sample analysis service provider before expanding into the global market. “We aspire to develop into a trusted company that facilitates the success of clinical trials for developers and partners, not just in Korea but throughout Asia and globally, backed by world-class infrastructure, quality, and service,” Yang stated. “You can expect to see tremendous changes in the next five years,” he added.

Source : Envisioning a Korean edition of 'Q-Square': GCCL Next celebrates its 5th anniversary with a global focus < The interview < ENGLISH NEWS < 기사본문 - 더바이오 (thebionews.net) 

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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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2024. 05. 24

[PR] GCCL Leverages ddPCR to Enhance Gene/cell Therapy Clinical Trial Services

Introduced the first ddPCR device in Korea to provide high-quality clinical trial sample analysis services by increasing test accuracyDifferentiate global lab services for cell and gene therapy clinical trials with cutting-edge technologyGCCL, 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 GCCLGCCL, 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.Source : GCCL Leverages ddPCR to Enhance Gene/cell Therapy Clinical Trial Services (prnewswire.com) 

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2023. 11. 20

[PR] Elevating Clinical Trial Services to New Heights

South Korea's ascent to becoming one of Asia's top clinical trial sites has been nothing short of remarkable, with Seoul consistently ranking within the top 5 world clinical trials by city annually. However, in the past, clinical trial samples from Korea often detoured to countries like Singapore, which have major central labs.Recognizing the need for a specialized lab to provide tailored services for the increasingly complex demands of clinical trial sample analysis, South Korea-based Global Clinical Central Lab (GCCL) was established in 2019 as a joint venture between GC Cell and C&R Research.By blending the local expertise of a regional lab with the capabilities of a global giant, GCCL's vision extends far beyond its domestic boundaries, rewriting the script of clinical trial support. It caters to new drug development companies such as bioventures, pharmaceutical companies, CRO companies, and hospitals.What sets GCCL apart is its unique combination of central lab and bio-analytical functions. While many other central labs in Korea outsource their bio-analytical analysis, GCCL provides customized analysis services for all clinical trial phases, from Phase 1 to 4. It possesses expertise in PK/PD, biomarker analysis, ADA, neutralizing antibody analysis, method development, and validation for small molecule drugs and biologics. This holistic, multifaceted approach positions GCCL as a one-stop shop for sponsors seeking comprehensive support throughout trials.Strengthening its bio-analytical services, the company has also increased its involvement in early-phase clinical trials of new drugs developed by pharmaceutical and biotech companies. With specialized Biosafety Level 3 facilities, GCCL also handles numerous projects on developing vaccines and therapeutics for infectious diseases. Approximately 30 percent of the COVID-related projects conducted in South Korea have been collaboratively undertaken with GCCL."In addition to our analysis services, we take immense pride in our project management prowess. We have embraced cutting-edge technology, implementing Thermo Fisher's LIMS to streamline analysis management. We have also developed our in-house system, G-HUB, which provides a customer portal for real-time project monitoring," says Song Hyun YANG, CEO of GCCL. "Combined with our meticulous lab-collection kit production and a nationwide logistics network, we ensure clients full visibility and transparency into the progress of their projects, from sample collection to final analysis."The company operates in alignment with international guidelines such as the FDA and EMEA and aims to establish itself as a prominent central lab in Asia. To achieve this, GCCL has partnered with over 15 harmonization labs worldwide, increasing its involvement in global projects. It also plans to expand through overseas-owned labs and offices, promising a greater global reach and impact.GCCL offers various proposals and tailored solutions to sponsors in multinational clinical trials. In a Phase 3 clinical trial across Korea, Asia, and Europe, GCCL played a pivotal role in cost reduction and efficiency optimization. By collaborating with a harmonization lab in Europe, GCCL reduced transportation costs by approximately USD 3 billion and reduced turnaround times by 2-3 days. This cost-effective solution highlights GCCL's commitment to delivering value to clients.In another project involving a Sample processing project across Asian countries, GCCL coordinated rapid sample processing and transportation to a specialized lab in Europe. This intervention successfully included Asian sites in the global project, demonstrating GCCL's adaptability and dedication to solving complex logistical challenges.Through innovative solutions and a commitment to excellence, GCCL offers tailored solutions that elevate the quality and efficiency of clinical trials. As it expands its global footprint, GCCL is set to leave an indelible mark on the field, shaping the way clinical trials are conducted worldwide.source : GCCL | Top Bioanalytical Services Company in Apac-2023 (lifesciencesreview.com)

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2023. 11. 20

[PR] GCCL Wins Top 10 Bioanalytical Services Providers in APAC 2023

Recognized for its global-quality sample analysis services based on various analytical platformsYONGIN, South Korea, Nov. 20, 2023 /PRNewswire/ -- GCCL, a Korean clinical trial sample analysis company, announced on November 20^th that it has been selected as the Top 10 Bioanalytical Services Providers in APAC 2023 awarded by Life Science Review, a U.S. business and technology magazine that focuses on the life science industry.Life Science Review publishes articles covering the advances in the fields of science, technology and solutions, biology, and more. At the end of every year, the magazine selects companies with innovative technologies based on a 3-stage selection process, including subscriber nomination and surveys. This achievement signifies the uniqueness and efficiency of the company's bioanalytical services that are based on the adoption of various analytical platforms.Life Science Review begins the article by commenting that "Seoul has consistently been ranking within the top 5 world clinical trial cities every year and while the past clinical trial samples from Korea often detoured to countries with major central labs, it has now become no longer the case." The article ends by assessing that "GCCL in Korea has been growing rapidly based on its expertise in the clinical trial sample analysis and is now expected to expand further through overseas-owned labs and offices, promising a greater global reach and impact."Song Hyun Yang, Ph.D. CEO of GCCL says, "We have embraced cutting-edge technology, implementing Thermo Fisher's LIMS to streamline analysis management. We have also developed our in-house system, G-HUB, which provides a customer portal for real-time project monitoring. Combined with our meticulous lab-collection kit production and a nationwide logistics network, we ensure clients full visibility and transparency into the progress of their projects, from sample collection to final analysis."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 global-quality services for all phases of clinical trials from phase 1 to 4. It has been recently strengthening clinical trial sample analysis for aging-associated diseases including dementia.About GCCLGCCL, 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.Source : GCCL Wins Top 10 Bioanalytical Services Providers in APAC 2023 (prnewswire.com)

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2023. 09. 05

[PR] GCCL to be the first in the industry sector to adopt Lab Information Management System (LIMS)

GCCL to be the first in the industry sector to adopt Lab Information Management System (LIMS)- The first clinical trial sample analysis provider to adopt LIMS- To provide enhanced quality of pharmacokinetic, pharmacodynamic, and immunogenicity data from bioanalytic testingGCCL, a Korean clinical trial sample analysis company, announced on Sep. 5^th that it has adopted the Lab Information Management System for the first time in the sample analysis industry.Thermo Scientific™ Watson™ LIMS by Thermo Scientific, which GCCL has adopted this time is a well-known software widely used by many global CROs, pharma companies and regulatory authorities. It is known to support the entirety of bioanalytic workflow from assay validation for pharmacodynamic analysis of biologics and chemical pharmaceuticals to sample analysis and reporting. According to GCCL, the company has even added the Immune Response Module that supports the immunogenicity analysis workflow in order to provide more enhanced bioanalytic services.Song Hyun Yang, CEO of GCCL, said, "Striving for better data accuracy is at the core of our company as a sample analysis service provider." And he added that "with the introduction of LIMS, we provide a high-quality sample analysis service that adheres to the global guidelines".With the server in place, GCCL is planning to complete the Computer System Validation (CSV) and start applying the system for pharmacodynamic analysis of chemical and biologic pharmaceuticals as well as for immunogenicity analysis of biopharmaceuticals from Q1 next year.About GCCLGCCL, 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 meets the 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 : NewsChannel10 (GCCL to be the first in the industry sector to adopt Lab Information Management System (LIMS) (newschannel10.com) )

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2023. 03. 18

[PR] GCCL Develops PBMC Resource Management System

GCCL Develops PBMC Resource Management SystemTo enhance accuracy and credibility of sample management and provide real-time information for customersGCCL(Global Clinical Central Lab), a company specializes in clinical trial sample analysis, announced on Mar.17 that it has built a resource management system for Peripheral Blood Mononuclear Cells (PBMCs), or PBMC Resource Management System.Under the PBMC Resource Management System, the whole process of PBMC testing, from the arrival of an original sample, centrifugation, and production of vials for split sample PBMC, to storage, dispatch mapping and disposal, is managed and stored in a computerized system using 2 barcodes.The system creates exclusive barcodes for each original and split samples after mapping, and the end-to-end testing cycle is computerized in the system. This will prevent human errors from manual entry and allow real-time data provision upon customer request."With more and more clinical trials for new biologic drug development, such as immunotherapy drugs require Cell Mediated Immunogenicity (CMI) analysis, we have decided to build this IT system to ensure excellent PBMC production and management services for customers.", said Hee-Joo Lee, Vice President of GCCL Lab Operation. She added, "This system development is expected to bring safer, more efficient and credible sample management services."About GCCLGCCL, 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 meets the 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.PR Newswire (https://www.prnewswire.com/news-releases/gccl-develops-pbmc-resource-management-system-301774708.html)

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2022. 05. 31

[PR] GCCL launches vaccine and treatment neutralizing antibody titers' analysis service

GCCL launches vaccine and treatment neutralizing antibody titers' analysis serviceGlobal Clinical Central Lab (GCCL), a subsidiary of GC Cell, said it would provide an analysis service of neutralizing antibodies of vaccines and therapeutic agents for infectious viral diseases from June.Only specialized institutions equipped with biosafety knowledge and analytical technology can perform neutralizing antibody analysis using live viruses.The services introduced by the lab include two methods -- plaque reduction neutralization test (PRNT) and the focus reduction neutralization test (FRNT)-- preferentially required when confirming the efficacy of a substance during clinical trials. The lab stressed that both assays have advantages such as high reproducibility and objectivity.Notably, the FRNT method reduces the measurement time of neutralizing antibodies, which normally takes about five to 10 days, to two to three days. Also, it allows simultaneous measurement of multiple neutralizing antibodies, according to GCCL.The lab explained that after establishing this analysis service, it has completed verification using the World Health Organization (WHO) standard serum used to verify the service and will be able to provide services from basic research fields, such as live virus-based candidate material verification and disease model research to research fields requiring various special facilities."The lab expects to help developers conduct clinical trials for developers, as they struggle with a lack of neutralizing antibody analysis facilities for new and mutated infectious disease," said Hee-Joo Lee, head of GCCL Lab Operations. "We will continue to expand various services for our customers."GCCL is a good clinical laboratory practice (GCLP)-certified laboratory that provides full-cycle analysis services from phase 1 to phase 4 clinical trials.Based on the company's sample transport and logistics system and various analysis platforms that meet global quality standards, the company supports the analysis of clinical trial samples from partners in Asia and around the world, GCCL said.About GCCLGCCL, 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 meets the 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.Korea Biomedical Review (https://www.koreabiomed.com/news/articleView.html?idxno=13784)

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