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事業内容

Large Molecule Services

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Medicilon offers comprehensive and FDA/CFDA GLP-compliant bioanalysis services to support preclinical and clinical development for small molecule drugs, biologics, vaccines and biomarkers.

Large molecule drugs bioanalysis service

Highlights

  • Established in 2015 with many experienced scientists
  • Comprehensive information management
  • Validated Watson LIMS for sample and data management
  • Operation in Shanghai for global support

Capacity

  • Immunoassay Development and Validation of methods for quantitation of drug substances in biological matrices
  • Protein &Peptide &Antibody Drug Analysis
  • Biomarker Screening&Analysis
  • Immunogenicity (ADA)
  • Vaccine

State-of-the-Art Equipment

  • MSD Sector Imager 6000  
  • MoleculeDevices M2/M4/M5 reader  
  • UV 2600 spectrometer 
  • BioTek ELx405 Select 
  • Hamilton workstation  

Large molecule bioanalysis method development & Validation

  • Development,Transfer, Optimization and Validation of Ligand binding Assay methods for quantitation of drug substances in biological matrices
  • Dozens of bioanalysis methds related to Adalimumab, Bevacizumab, Trastuzumab, Pertuzumab and Antibody Drug Conjugate(ADC) were validated and available for use
  • Quick validation to support potential studies

Protein&Antibody& Peptide Drug Analysis

  • Preclinical and Clinical studies conducted in any countries around the world
  • PK/PD/Immunogenicity
  • BE study

Biomarker Testing

  • Inflammation markers
  • Tumor markers
  • Metabolic Markers
  • Cardiovascular markers
  • Bone markers

Vaccine Study

  • Single&Multi-valent vaccine
  • Multi-serotypes antibody assay
  • High through-put&automation

Immunogenicity(ADA)

  • Screening
  • Confirmatory
  • Titration

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