Smithers Avanza Resource Library

 

 

Use of Two Technologies, Singulex Single Molecule Counting (SMC)™ and Meso Scale Discovery® (MSD) Technology For Drug Levels Determination of an Antibody Therapeutic, MK-A, in Human Serum in A Dose Escalation Study

 

MK-A is an immunomodulator molecule that is used in oncology treatments. Due to the unknown potential effects of the drug on immune system, the regulatory agency has advised to conduct dose escalation study starting with pg/mL. Singulex Erenna platform was used to address low sensitivity assay requirements, and higher drug concentrations were measured by the well-established MSD technology. The two PK (pharmacokinetic) methods were validated and bridged to demonstrate comparability using Cmax level dilutional control samples.