Assays

Somru developed the following comprehensive list of  bioanalytical assays to support Denosumab biosimilar  development  Pharmacokinetic Assay (PK) assay  ADA assay  Binding ADA assay  Cell-based NAb assay(s)  Ligand Binding NAb Assay   Pharmacodynamic Assays  sCTX  TRAP-5b  P1NP PK Assays to support Denosumab   Somru has developed an assay to support the pharmacokinetic  measurement of Denosumab   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 1. SPEAD method  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  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  Ready to get started? Consult with a Scientist today! Let's Talk