Somru BioScience

A comprehensive bioanalytical solution for Denosumab(Prolia®, Xgeva®)

Somru developed the following comprehensive list of  bioanalytical assays to support Denosumab biosimilar  development 

  1. Pharmacokinetic Assay (PK) assay 
  2. ADA assay 
  • Binding ADA assay 
  • Cell-based NAb assay(s) 
  • Ligand Binding NAb Assay  
  1. Pharmacodynamic Assays 
  • sCTX 
  • TRAP-5b 
  • P1NP

PK Assays to support Denosumab 

  1.  Somru has developed an assay to support the pharmacokinetic  measurement of Denosumab 
  2.  This assay utilizes the target (RANKL) as the capture and anti Denosumab for detection 
  • Sensitivity – 25 ng/mL ELISA 
  • Range: 2000 – 25 ng/mL

ADA Assay to support Denosumab

  • SPEAD method involves extraction of ADA from solid  phase bound to biotin-Drug 
  • The assay utilizes acid dissociation  
  • Depending on lot of positive control, ELISA sensitivity is  less than 100 ng/ml using a polyclonal rabbit affinity  purified antibody 
  • Drug tolerance – 20 µg/mL 

1. SPEAD method 

2. Somru does not recommend the use of SPR method due to the sensitivity  requirements of regulatory authorities and matrix effect 

Neutralizing Antibody Assay

 Cell-based Nab Assay 

  • Utilizes RAW 267.4 cell line – This is macrophage-like, Abelson leukemia virus  transformed cell line derived from BALB/c mice. The end point is measurement  of TRAP using an ELISA assay. The assay is highly variable. To overcome this,  we have developed a reporter-cell line based NAb assay. 
  • Reporter-cell line-based NAB assay – utilizes modified cell line with reporter  gene utilizing RANK/RANKL interaction to verify neutralizing antibody
  •  Ligand binding NAb assay – Somru has also developed a ligand binding  method for the detection of NAbs.  
  •  Sensitivity – 500 ng/mL 

Pharmacodynamic Assay

Somru has validated antibody pairs for the measurement of the following  biomarkers in ELISA or ECL format in a functionally relevant manner to  support Denosumab biosimilar development 

  • sCTX 
  •  TRAP-5b 
  •  P1NP 

Somru BioScience Product list

  1. Denosumab (Xgeva®)- Characterization ELISA
  2. Denosumab (Prolia®) ADA
  3. Denosumab PK

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