Patent ID: 9638696
Date: 2017-05-02
CPC Classifications: G01N

Claim:
1. A process for detection and quantification of trastuzumab in a biological sample, said process comprising: (a) diluting the biological sample with a modified citrate buffer comprising citrate-HCl at a concentration of about 125 mM and polysorbate-20 at a concentration of about 0.1% w/v, the modified citrate buffer having a pH of 3.5, and (b) performing an assay to detect and quantify trastuzumab in the biological sample, wherein the biological sample comprises at least one interfering substance that binds trastuzumab, wherein the at least one interfering substance is an extracellular domain of HER-2 (HER-2-ECD) and wherein said interfering substance and trastuzumab combine to form a complex in the biological sample.