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.

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You can find out more about our Bio Analytical Lab in the leaflet below :-)

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We will always continue to be the best clinical trial partner for our customers.
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