Bioanalytical Lab
GCCL provides various services in developing and verifying analysis methods
and analyzing biomarkers based on state-of-the-art equipment
and specialists for PK/PD analysis in early clinical trial phases.
By Platform
> Bio-Analytical Lab > By Platform
Immunoassay
LBA Platform
LBA (Ligand Binding Assay) is an analytical technique that quantifies or qualitatively assesses interactions between two molecules. GCCL is equipped with a range of analytical instruments, including VersaMax, SpectraMax ID3, FLUOstar Omega, Luminex 200, MESO™ QuickPlex SQ 120MM (MSD), and SIMOA. Our services include pharmacokinetic (PK) analysis of biopharmaceuticals, immunogenicity testing, neutralizing antibody analysis for vaccines (FRNT), biomarker analysis, and the development of customized Cell-Based Assays to meet specific client requirements.
Service
- Bioanalytical Method Development & Validation
- Large Molecule Drug PK Study
- Large Molecule Drug Immunogenicity Study
- Vaccine Immunogenicity Study (FRNT for NAb)
- Biomarker Analysis
Platform
- FLUOstar Omega
- Luminex 200
- MESO™ QuickPlex SQ 120MM (MSD)
- SpectraMax ID3
- SpectraMax M5
- SIMOA
- VersaMax Z
Experience
- Oncology
- Inflammatory Disease
- CNS
- Infectious Disease
- Cell & Gene Therapy
- Ophthalmology
- Musculoskeletal Disorder
- Rare Disease
- Cardiovascular Disease
- Immunology
- Endocrine & Metabolism
- Dermatology
Immunoassay
FACS
FACS (Fluorescence-Activated Cell Sorting) analysis is a technique that enables the detection and classification of cells by utilizing fluorescently labeled antibodies that bind to cell surface or intracellular components. GCCL offers a range of tailored analytical services through its FACSLyric platform, such as CAR-T cell analysis, lymphocyte subset type analysis, receptor occupancy assessment, and biomarker analysis.
Service
- Bioanalytical Method Development & Validation
- Cell & Gene Therapy Drug PK Study
- Cell & Gene Therapy Drug Immunogenicity Study
- Lymphocyte Subtype Analysis
- Immunogenicity Analysis
- Receptor Occupancy Analysis
- Biomarker Analysis
Experience
- Oncology
- Infectious Disease
- Cell & Gene Therapy
- Dermatology
- Inflammatory Disease
- Immunology
Nucleic Acid Analysis
PCR Platform
PCR (Polymerase Chain Reaction) analysis is the most widely used technique for nucleic acid analysis. GCCL provides advanced analytical capabilities with conventional qPCR systems, as well as the QX ONE Droplet Digital PCR System for absolute quantification and the KingFisher Flex, an automated instrument designed for nucleic acid extraction from diverse biological samples, including blood. Our services encompass customized analyses for cell and gene therapy clinical trials, virus detection, and gene expression quantification.
Service
- Bioanalytical Method Development & Validation
- Cell & Gene Therapy Drug PK Study
- Cell & Gene Therapy Drug Immunogenicity Study
- Viral Detection Test
- Gene Expression Analysis
Platform
- QX ONE Droplet Digital PCR System
- 7500 FAST
- 7500
- Qubit Flex Fluorometer
- Kingfisher Flex
Experience
- Cell & Gene Therapy
- Oncology
- Infectious disease
- Rare disease
Mass Analysis
LC-MS/MS
LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry), commonly referred to as mass spectrometry, is an analytical method that allows highly accurate quantification by determining the exact molecular mass of a substance. GCCL utilizes state-of-the-art equipment, including the Sciex Triple Quad 6500 system, to offer comprehensive analytical services, such as PK analysis of small-molecule therapeutics and peptides, metabolomics studies, and pharmacokinetic evaluation of antibody-drug conjugates (ADCs).
Service
- Bioanalytical Method Development & Validation
- Small Molecule Drug PK Study
- Small Molecule Bioequivalence Study
- Large Molecule Drug PK Study (ADC)
- Peptide Drug PK Study
Platform
- Sciex Triple Quad 4500 system
- Sciex Triple QuadTQ 5500 system
- Sciex Triple Quad 5500+system
- Sciex Triple Quad 6500 system
Experience
- Oncology
- MASH
- CNS
- Inflammatory Disease
- Rare disease
- Ophthalmology
- Infectious Disease
- Cardiovascular Disease
- Endocrine & Metabolism
- Immunology
Other Biomarkers Analysis
ELISpot
ELISpot analysis detects cytokines secreted by cells using the Ligand Binding Assay (LBA) method to assess cell-mediated immune responses. GCCL utilizes advanced instrumentation, including the Mabtech ASTOR and ImmunoSpot® S6 Universal M2 Analyzer, to offer comprehensive analytical services such as immunogenicity evaluation for biopharmaceuticals and vaccines.
Service
- Large Molecule Drug Immunogenicity Study
- Vaccine Immunogenicity Study
Platform
- Mabtech ASTOR
- ImmunoSpot® S6 Universal M2 Analyzer
Experience
- Oncology
- Cell & Gene Therapy
- Infectious disease