Medicilon LBA department offers comprehensive and FDA/ CNDA GLP-compliant bioanalysis services to support preclinical and clinical development for Large molecule drugs, vaccines and biomarkers.
Highlights
- GLP lab established with experienced scientists
- Support preclinical and clinical studies conducted in any countries around the world
- Validated Watson 7.4.1 LIMS for sample and data management
- US FDA inspected and CNDA GLP-certified
Capabilities
- Antibody production and labeling
- Immunoassay Method Development/Transfer/optimization& Validation
- T-Cell Immunotherapy
- Biomarkers
- Vaccine
- Immunogenicity
Instruments and Equipments
- Meso Scale Discovery SECTOR Imager S600
- Molecular Devices SpectraMax i3x, M4, and M5 Plate Readers
- BioTek ELx405 Select Microplate Washer
- Hamilton Automated Liquid Handling Workstation
- Gyrolab xPlore
- Applied Biosystems 7500 Real Time PCR System
- GE Biacore 8K
- Bio-Plex 200 Multiplex Immunoassay System
Antibody production and labeling
- Animal immunization(Mouse/Rat/Rabbit/Dog/Monkey)
- Affinity purification
- HRP/Biotin/FITC/Ruthenium labeling
Immunoassay Method Development/Transfer/optimization& Validation
- PK/TK Assays
- ADA Assays
- Support GLP pre-clinical studies and clinical studies
- Support peptide, Antibody, Antibody fragment & Protein Drug Analysis
Bioassay for T-Cell Immunotherapy
- qPCR
- Cytokine storm
- Immunogenicity
Biomarker services
- Cytokines
- Toxicity biomarkers
- Tumor biomarkers
- Metabolic biomarkers
- Cardiovascular biomarkers
- Bone biomarkers
Vaccine services
- Multi-valent vaccine assay
- Multi-serotypes antibody assay
- Vaccine immunogenicity
Drug Immunogenicity Analysis
- Screening assay
- Confirmatory assay
- Titration assay
- Cell-based neutralizing antibody detection
One-station service platform for Protein, Antibody, Vaccine, ADC and Peptide
