Home » Therapeutic Antibody » Lead Discovery
Target
    4 Immunogens Choices
  • DNA, Peptide, Protein, Cell & combination
Binder
Functional Ab Lead
Functional Optimized Lead with good manufacturability
Optimized Lead with
good biological
efficacy, safety &
manufacturability
In Vivo Efficacy, Exploratory PK & Toxicity Studies
    Deeper Insights in Animals
  • In Vivo Efficacy
  • Exploratory PK & Toxicity Studies
PK and ADA Analysis
Anti-Idiotype Antibody
Discovery Services Testing Options Deliverables Timeline
M1: Antibody Lead Generation Bioassays
  • Project report
  • 10 hybridoma clones for cryopreservation
  • Antibody characterization data
  • 3-5 antibody leads (purified antibody & sequence)
6-8 months
  • Immunogen preparation (Peptide, recombinant protein, cell line, DNA or combination)
  • Animal immunization
  • Cell fusion & screening
  • Subcloning & screening
  • Hybridoma scale-up
Biochemical & Biophysical Assays
  • ELISA, FACS, & Biacore
  • Antibody sequencing, epitope binning, cross-reactivity test, etc.
Functional Assays
  • Proliferation, growth inhibition & apoptosis assay
  • MLR & cytokine release assay
  • Neutralization assay
  • Phagocytosis, internalization & endocytosis assay
  • ADCC, CDC & ADCP assay Reporter Gene assay
M2: Antibody Lead Optimization In Vivo Efficacy, Exploratory PK & Toxicity Studies
  • Project report
  • 2-3 optimized antibody leads ( purified antibody & sequence)
  • Efficacy report
  • PK & Toxicity report
6-7 months
  • Antibody Humanization
  • Developability Assessment
  • Antibody Affinity Maturation
  • Partnership with Qualified Vendors
  • Project Management by GenScript ProBio

Lead Generation

  • 12 antibody leads recognizing 2 distinct epitopes were obtained.
  • 2 antibody leads with different epitopes were moved forward to lead optimization.
  • elisa-ec50
  • elisa-ic50
  • functional-assay

Lead Optimization

  • 2 antibody leads were humanized and then tested by functional assay.
  • Their developabilities were evaluated by both experimental & predicted approaches.

Antibody Humanization

Ligand Analyte ka (1/Ms) kd (1/s) KD (M) Rmax (RU) Chi² (RU²)
Chimeric lgG Antigen/His 4.67E+05 1.00E-05 2.14E-11 38.3 3.40E-02
Humanized Ab Lead 7.05E±05 1.00E-05 1.42E-11 38.2 5.28E-02
reference

Manufacturability Assessment

Thermostability (Tm) >60 °C (by DSC)
Extra Cys No hotspot predicted, confirmed by Mass Spec
N-glycosylation
Asn deamidation
Asp isomerization
Hydrolysis
Oxidation 2 hot spots predicted and confirmed by Mass Spec,
Not impact binding by Biacore & on stability by SEC under forced oxidation


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