Biosimilars

Custom Biologics™ offers a comprehensive range of sophisticated methods to characterize, compare and clinically assess monoclonal antibodies and their biosimilars.

 

 

Avastin (bevacizumab) (anti-VEGF)

Binding assays:

  • VEGF Binding
  • Fc-Gamma Receptor Binding
  • FcRn Binding
  • C1q Binding

Cell-based assays:

  • Inhibition of Proliferation
  • Complement Dependent Cytotoxicity (CDC)
  • Antibody Dependent Cellular Cytotoxicity (ADCC)

Enbrel (etanercept) (anti-TNF-alpha)

Binding Assays

  • TNF-Alpha Binding
  • Fc-Gamma Receptor
  • FcRn Binding
  • C1q Binding

Cell based assays

  • TNF-Alpha Neutralisation
  • Complement Dependent Cytotoxicity (CDC)
  • Antibody Dependent Cellular Cytotoxicity (ADCC)

Forteo (Teriparatide/Parathyroid hormone)

Cell-based assays:

  • Inhibition of Proliferation

Humira (adalumimab) (anti-TNF-alpha):

Binding Assays

  • TNF-Alpha Binding
  • Fc-Gamma Receptor
  • FcRn
  • C1q

Cell based assays:

  • TNF-Alpha Neutralisation
  • Complement Dependent Cytotoxicity (CDC)
  • Antibody Dependent Cytotoxicity (ADCC)

Lucentis (ranibizumab) (anti-VEGF)

Binding assays:

  • VEGF Binding

Cell-based assays:

  • Inhibition of Proliferation

Remicade (infliximab) (anti-TNFa)

Binding Assays:

  • TNF-Alpha Binding
  • Fc-Gamma Receptor
  • FcRn Binding
  • C1q Binding

Cell based assays:

  • TNF-Alpha Neutralisation
  • Complement Dependent Cytotoxicity (CDC)
  • Antibody Dependent Cellular Cytotoxicity (ADCC)

Rituxan (rituximab) (anti-CD20)

Binding assays:

  • CD20 Binding
  • Fc-Gamma Receptor
  • FcRn Binding
  • C1q Binding

Cell-based assays:

  • Inhibition of Proliferation
  • Complement Dependent Cytotoxicity (CDC)
  • Antibody Dependent Cellular Cytotoxicity (ADCC)

Cytokines

Betaseron/Betaseron (Interferon-β 1 beta)

Cell Based assays:

  • Immunogenicity
  • Cytopathic protective effect assay

Pegasys (peginterferon α-2a)

Cell Based assays:

  • Immunogenicity
  • Cytopathic protective effect assay

Neupogen (filgrastim) (GCSF)

Cell Based assays:

  • Inhibition of proliferation assay

Neulasta (pegfilgrastim) (peg-GCSF)

Cell Based assays:

  • Inhibition of proliferation assay

Cell based mechanism of action and immunogenicity assays in development:

  • Erythropoietin (Epo)
  • Ustekinumab, (anti-IL-2 and IL-23)
  • Tocilizumab (IL-6 receptor antagonist)
  • Canakinumab (anti-IL-1b)
  • Daclizumab (IL-2 receptor antagonist)
  • Certolizumab pegol (anti-TNF-a)