R&D CRO

서비스 scope(세부항목)

BC TOP platform 세부 항목

• Step1

  Target Discovery

  Target validation

  • RNA seq 분석 데이터
  • 유전체 분석

  Lead Antibody Discovery

  • Mouse hybridoma approach
  • Humanization

• Step2

  Assay Development

  Cell based assay

  • MSD multiplex assay
  • Cytotoxic assay
  • Receptor Occupacy assay
  • in vitro safety (cytokine release assay)
  • Binding affinity and functional activity
    - FcyR binding
    - ADCC/CDC activity
  • CAR-T cell cytokine release assay

• Step3

  Lead candidate optimization

  Lead Optimization

  • Cell based assays
  • in vivo efficacy studies via animal models
  • PK/PD
  • Safety assessment
    (non-GLP-Tox)
  • Immunohistochemistry (IHC)
    - Tissue Cross reactivity (TCR)
    - Cytokine release assay

• Step4

  Preclinical pharmacology

  Pre-clinical Pharmacology

  • Dose range finding
    - PK/PD profile
    - Estimate of human dose
  • Short Term Toxicology study (2-4 weeks)
    - Hematology
    - Immune histopathology
    - Cytokines
  • Biomarker and imaging
    - Multiplex IHC (7- target)
    - IHC
    - Immune cell FACs analysis