2025. 04. 17

GCCL Provides Full-Cycle Lab Services for the Approval of GC Biopharma’s Anthrax Vaccine

GCCL, as the central lab for the clinical development of GC Biopharma’s anthrax vaccine “BARYTHRAX(GC1109),” which was recently approved by the Ministry of Food and Drug Safety (MFDS), provided full-spectrum analytical support across the non-clinical and clinical phases, playing a pivotal role in the vaccine’s successful development.Jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA) in preparation for national biosecurity threats such as bioterrorism, BARYTHRAX is Korea’s 39th domestically approved new drug, receiving MFDS approval on April 8, 2025.BARYTHRAX is the world’s first recombinant protein anthrax vaccine, created using genetic recombination technology to produce protective antigen (PA) proteins that deliver two types of anthrax toxin components into cells. This triggers an immune response via PA, effectively preventing anthrax infection. Throughout the vaccine’s development, GCCL provided end-to-end support—spanning bioanalytical method validation, sample analysis, central lab operations, and MFDS regulatory inspection readiness—ensuring analytical excellence at every step.✅ Validated Anti-PA IgG and TNA assays across the full clinical timelineIn the non-clinical stage, GCCL successfully conducted toxin neutralization assays (TNA) for protective antigens (PA) using rabbit serum samples.During clinical trials, ELISA-based Anti-PA IgG and TNA methods were rigorously validated following international guidelines.These validated methods were used for precise analysis of clinical samples, providing high-quality data throughout the study.✅ GCLP-certified central lab operations and multi-site coordinationAs a fully GCLP-certified central lab, GCCL oversaw the entire lifecycle of clinical sample management, including collection, transport, storage, preprocessing, and analysis across multiple clinical sites in Korea.Through systematic processes and stringent quality control, GCCL ensured data consistency and integrity,even in the complex landscape of multi-site clinical trials—contributing significantly to the reliability and success of the vaccine’s development.✅ Successful participation in MFDS regulatory inspectionGCCL also played a direct role in the MFDS clinical trial site inspection, successfully demonstrating the lab’s technical expertise and quality systems.Our data and management processes served as a critical foundation for regulatory approval,helping to bring Korea’s first anthrax vaccine to commercialization.We are proud to have meaningfully contributed to a project of national significance from beginning to end.This approval exemplifies how GCCL supports technological self-reliance in Korea’s vaccine development ecosystem.With world-class infrastructure and deep expertise in infectious disease analysis, GCCL remains committed to leading the delivery of high-quality analytical solutions for the development of vaccines and biopharmaceuticals worldwide.Click the banner below to learn more about GCCL!

2025. 04. 08

GCCL’s Participation in the 2025 Spring Conference of KSCPT

GCCL will participate as an exhibitor at the 2025 Spring Conference of the Korean Society for Clinical Pharmacology and Therapeutics (KSCPT), which will be held at Seoul National University Siheung Campus from Wednesday, April 16 to Thursday, April 17, 2025.  This year’s conference, held under the theme “Advancement of Clinical Pharmacology Research through Data Science,” will showcase a wide range of research achievements that apply cutting-edge data-driven technologies—such as real-world data (RWD), real-world evidence (RWE), machine learning, and artificial intelligence (AI)—to the field of clinical pharmacology.We are pleased to provide a brief introduction to the GCCL promotional booth that will be featured at this year’s conference. 🏢 GCCL Booth InformationDate & Time: Thursday, April 17, 2025 | 09:00–18:00Location: Booth No. 1, next to the registration desk, Seoul National University Siheung CampusOur affiliate company, C&R Research, will also be joining us at Booth No. 2. We look forward to seeing you there! :)Visitors to the GCCL booth will receive exclusive 2025 promotional items prepared by GCCL.By visiting our booth, you’ll have the opportunity to learn more about GCCL’s latest clinical trial sample analysis services. We warmly welcome your interest and visit!For more details, please refer to the promotional materials and link provided below.🔗 Conference Information: Learn MoreWe will continue to be your trusted partner in clinical trials, committed to delivering value and earning your confidence every step of the way. 

2025. 04. 03

Bio Analytical Lab for Clinical Trials

The Bio Analytical Laboratory at GCCL performs assay development and validation, as well as PK/PD, ADA, NAb and biomarker analyses to support drug development and biological research.To ensure high accuracy and reproducibility, we are equipped with a variety of state-of-the-art platforms, including LBA platforms, LC-MS/MS, ddPCR, qPCR, FACS and ELISpot. We provide reliable bioanalytical services from early-phase clinical trials through the entire drug development process, all in accordance with global guidelines.📑 Method Development & Validation📌 Consulting for method development📌Method development and validation according to guidance by ICH M10, FDA, EMA, CLSI, etc📌 ELISA, MSD, LC-MS/MS, qPCR, FACS, etc.🧬 Pharmacokinetics (PK)📌 LC-MS/MS - Simultaneous metabolic analysis, Synthetic / Improved new drugs, etc.📌 LBA - Biologics, Antibody drugs, etc.📌 qPCR / ddPCR - Cell & Gene Therapy🥼 Pharmacodynamics (PD)📌 Experienced in analyzing PD markers more than 250📌 Blood - Inflammation, Cytokine, Lipid, NGS, etc.📌 Tissue - Multiplex IHC, NGS, etc.📊 Anti-drug Antibody (ADA)📌 Performing screening assay, confirmatory assay, and titer assay through method development & validation📌 LBA - Biologics, Antibody drugs, etc.📌 qPCR / ddPCR- Cell & Gene Therapy🧪 Biomarkers📌 Biomarker analysis service using various platforms📌 Singleplex : ELISA, MSD, SIMOA📌 Multiplex : Luminex, MSD, SIMOA📌 FACS, qPCR / ddPCR, Sequencing, IHC, etc.You can find out more about our Bio Analytical Lab in the leaflet below :-)We will always continue to be the best clinical trial partner for our customers.Click the banner below to learn more about GCCL!

2025. 04. 01

GCCL Obtains ISBER Certification

GCCL participated in the 2024 Biorepository Proficiency Testing Program – Viable PBMC Isolation,organized by the Integrated Biobank of Luxembourg (IBBL), a global standard-setting organization for biospecimens.Based on the evaluation results, GCCL was granted a certificate of participation, meeting all required standards.  GCCL has continued to receive this certification, gradually building international recognition for its growing capabilities in the PBMC field. This internationally recognized proficiency testing program adheres to the standards of the International Society for Biological and Environmental Repositories.It assesses the accuracy and reproducibility of PBMC (Peripheral Blood Mononuclear Cell) isolation, as well as the quality control of biological samples.The evaluation was conducted by the ISBER Proficiency Testing Advisory Group, comprising experts from various countries.The official results were released in March 2025. The certification awarded to GCCL includes the official recognition that all evaluation criteria were successfully met, along with our participant number (L630).This participation allowed GCCL to confirm its technical capability and quality system in alignment with international standards. GCCL has a team with experience in PBMC processing and continues to build expertise through active engagement in the field.With the introduction of a computerized system to support secure and reliable specimen management, we are continuously working to enhance service quality.We hope this certification will serve as a step toward building greater trust in our PBMC isolation services among global partners and clients.For more detailed information about GCCL’s PBMC Isolation services, please refer to the attached file.Moving forward, GCCL will continue to validate its quality management system through regular international certifications,and strive to grow as a clinical trial sample analysis organization that aligns with and contributes to advancing global standards.

2025. 03. 31

2025 1Q Newsletter

2025. 03. 12

GCCL ISO 15189 accreditation has been extended until 2029

In March 2025, GCCL received an ISO 15189 certification extension approval (KOLAS-accredited medical testing laboratory), allowing the certification to be maintained until 2029.ISO 15189, established by the International Organization for Standardization (ISO), is a globally recognized certification that verifies the quality and technical competence of medical testing laboratories. It serves as an international standard, ensuring that all clinical trial specimen analysesmeet the highest standards of accuracy, reproducibility, and reliability.Since obtaining its initial ISO 15189 certification in 2021, GCCL has continuously enhanced its quality management and technological innovation to provide world-class specimen analysis services. This four-year certification extension reaffirms that GCCL's clinical trial sample analysis services meet global standards and uphold the highest levels of accuracy and credibility.✅ ISO 15189 certification obtained in 2021, followed by continuous quality improvement ✅ The first central lab in Korea to provide full-cycle specimen analysis services, from Phase 1 to regulatory trials ✅ Ongoing enhancement of analytical capabilities for global clinical research and multinational pharmaceutical collaborations GCCL will continue to provide global-standard sample analysis services as an ISO 15189-certified institution, leveraging state-of-the-art platforms and a stringent quality management system to maximize the accuracy and efficiency of clinical trial specimen analysis.  

2025. 02. 27

Central Lab Services in GCCL

🔬 𝐀𝐜𝐜𝐞𝐥𝐞𝐫𝐚𝐭𝐞 𝐘𝐨𝐮𝐫 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 𝐰𝐢𝐭𝐡 𝐆𝐂𝐂𝐋’𝐬 𝐂𝐞𝐧𝐭𝐫𝐚𝐥 𝐋𝐚𝐛 𝐒𝐞𝐫𝐯𝐢𝐜𝐞𝐬!We are excited to introduce our latest brochure, showcasing GCCL’s comprehensive central lab services designed to streamline multi-national and multi-site clinical trials.With our integrated system, we ensure efficiency, consistency, and high-quality data management across all phases of clinical research.Discover how our central lab solutions can support your clinical trial success.🌎 Global Network & Quality AssuranceTo provide accurate and consistent analytical results across distributed test sites,we work with our partner labs around the world to establish common baselinesand quality assessments.- 10+ years of experience across 15+ countries- Global QC standardization for consistent results- ISO 15189, CAP, NGSP, ISBER accredited🧪 Comprehensive Lab CapabilitiesWe provide clinical trial specimen analysis services for a wide range of samples.- Clinical Lab | Bio-analytical Lab | R&D Lab- Biomarker profiling, PBMC isolation, genetic testing- Safety & efficacy testing across multiple disciplines📦 End-to-End Sample & Logistics ManagementManage sample collection, transportation, and storage & biorepositorythroughout a clinical trial, to increase efficiency andspeed in the clinical trial process and ensure sample safety.- Lab Kit production & Bio-Logistics services- Sample storage & biorepository- Real-time tracking via our in-house G-HUB systemYou can find out more about our Central Lab service in the leaflet below :-)We will always continue to be the best clinical trial partner for our customers.Click the banner below to learn more about GCCL!

2025. 02. 14

Take a Tour of the GCCL Lab!

GCCL has established a state-of-the-art laboratory to support global clinical trials, providing more reliable analytical results.We have created an interactive lab tour video to give you a closer look at our lab facilities and provide a detailed introduction to our services.For more details on our facilities and services, please check the video and the link below.🔗 Interactive Map - Click through the map to closely examine each facility.🎥 Lab Tour Video – Experience the lab as if you were there!☑️ GCCL Sample Management When samples arrive at the GCCL Sample Management Lab, which operates 24 hours a day, Samples are efficiently managed through our proprietary G-HUB program, which automates the entire process with a two-step barcode system.Afterwards, they are stored and managed in optimal conditions, and then delivered to each lab for customized analysis.☑️ GCCL R&D Lab GCCL’s R&D Lab is focused on proactively introducing technologies needed for clinical trials, and it develops and validates biopharmaceutical and biomarker analysis methods using state-of-the-art equipment.☑️ GCCL Bio Analytical Lab GCCL’s Bio Analytical Lab possesses expertise in PK/PD, ADA, and Biomarker analysis for early-stage clinical trials.To support the development of innovative therapies, from synthetic drugs to biopharmaceuticals, we equip ourselves not only with LBA platforms but also cutting-edge equipment such as LC-MS/MS, ddPCR, Real-Time PCR, FACS, ELISPOT, etc.Additionally, we are the first in the domestic industry to adopt Watson LIMS, enabling us to support high-quality sample analysis workflows in adherence to global guidelines.☑️ GCCL BL3 Lab GCCL operates facilities from BL1 to BL3.In the BL3/BL2 Lab, which exceeds 500m², we offer research services such as neutralizing antibody analysis for infectious disease vaccine research through the in-house production of live viruses, validation of therapeutic candidates in infectious models, and performance evaluation of virus diagnostic devices.☑️ GCCL Clinical Lab GCCL's Clinical Lab provides automated analysis and safety and efficacy tests for large-scale global phase 3. With more than 5,000 tests, we ensure the delivery of highly reliable analytical data.☑️ GCCL Lab Kit Room GCCL Lab Kit service provides all the necessary items for sample collection in one kit before specimen collection.GCCL supports projects by producing customized Lab Kits, allowing standardized sample collection for investigating sites.☑️ GCCL Project Management GCCL Project Managers play a crucial role in successful clinical trial analysis projects. They lead the project by adhering to relevant regulations, and utilizing an in-house developed program, G-HUB, they manage planning, system setup, operation, monitoring, and reporting.Through the G-HUB portal, clients can conveniently track real-time updates on sample pickups, transport, Lab Kit requests, analysis reports, and project progress anytime and anywhere.Likewise, GCCL provides top-tier clinical trial sample analysis services through our world-class facilities, equipped with cutting-edge analytical systems and a team of experienced professionals.If you have any questions, feel free to reach out anytime!

2025. 02. 05

GCCL Wins the 2025 Best Practices Customer Value Leadership Award from Frost & Sullivan

Today, we are excited to share the news that GCCL has been honored with the 2025 Best Practices Customer Value Leadership Award from Frost & Sullivan, recognizing excellence in the Asia Pacific (APAC) clinical sample analysis services industry.About the Frost & Sullivan Best Practices AwardsFrost & Sullivan is a global market research firm with over 60 years of history, recognizing companies that achieve growth through innovative services.The Best Practices Customer Value Leadership Award is presented only to companies that deliver outstanding value to their customers. The selection process involves rigorous evaluations based on multiple criteria, including Growth Potential, Customer Acquisition, Customer Experience, Operational Efficiency, and Brand Equity. After multiple rounds of assessments, GCCL was recognized as a leader in clinical sample analysis services.GCCL: A One-Stop Lab Solution for Clinical TrialsAt GCCL, we operate an integrated Central Lab, Bioanalytical Lab, and BL3 (Biosafety Level 3) facility, allowing us to:✅ Minimize sample movement, reducing costs and turnaround time✅ Enhance data reliability, ensuring high-quality results✅ Provide optimal analytical solutions, supporting successful drug developmentBeyond APAC, we collaborate with global partners to ensure compliance with FDA, EMA, and other major regulatory standards, delivering world-class clinical sample analysis services.In 2024, we established a dedicated R&D Unit and introduced cutting-edge platforms such as ddPCR and a global Laboratory Information Management System (LIMS) to provide more efficient and precise services tailored to our clients’ needs.Why Frost & Sullivan Recognized GCCLFrost & Sullivan highlighted GCCL’s strong internal capabilities, commitment to global quality standards, and continuous service enhancements as key factors in leading the APAC clinical sample analysis market. The following strengths set us apart:✅ All-in-One Clinical Trial LabUnlike other global central labs that often outsource services to different countries, GCCL integrates all essential lab functions within South Korea. This ensures:✔ Faster turnaround times✔ Greater sample stability✔ Seamless, high-quality data analysis✅ Tailored Solutions & Rapid Sample ProcessingWe provide customized analytical services based on client needs. Notably, our PBMC sample processing time is under 8 hours—more than 3 times faster than global labs, significantly improving efficiency for drug developers.✅ Advanced Technology & AutomationWe leverage state-of-the-art technologies such as:✔ BIO-RAD Evolis System – Ensuring consistent and automated bioanalytical testing✔ Droplet Digital PCR (ddPCR) – Enhancing precision in sample analysis✔ G-HUB Platform– Optimizing real-time sample tracking and data management✅ Customer-Centric ApproachGCCL goes beyond standard sample analysis, fostering close collaboration with clients to support their clinical research success.In our 2024 customer satisfaction survey, GCCL received outstanding ratings, reinforcing our reputation as a trusted industry partner.Read the Full Award ReportFor more details on the award, please refer to the official report: 🔗 Frost & Sullivan 2025 GCCL Award ReportLooking AheadThis award is not just an achievement—it is a testament to the trust and technological excellence GCCL has built through our customer-first approach.As a leading central lab in APAC, we are committed to expanding our global presence and delivering even greater value to pharmaceutical and biotech partners worldwide.Moving forward, we will continue to enhance our services, collaborate with global drug developers, and drive innovation in clinical sample analysis.Stay tuned as GCCL continues to push the boundaries of clinical research, supporting successful drug development worldwide. 🚀

2024. 12. 31

2024 4Q Newsletter