Sr. Director, Scientific Services KCAS Bio Olathe, Kansas
Description: In modern therapeutics, the accurate quantitation of monoclonal antibodies (mAbs) within complex biological matrices is paramount for ensuring therapeutic efficacy and patient safety. As such, the development of robust analytical methods capable of precisely measuring individual mAb components within multi-component drug products is of utmost importance. We present a cutting-edge liquid chromatography-multiple reaction monitoring-mass spectrometry (LC-MRM-MS)-based method, combined with trypsin digestion meticulously designed for the quantitative analysis of each mAb from a six-component antibody cocktail drug product in human serum matrix using a single workflow. This method is ready for validation in accordance with ICH M10 Bioanalytical Method Validation Guidelines. We present a case study that follows this validation process, including the potential use of a surrogate matrix and the detailed methodology and criteria behind the validation.
Learning Objectives:
Develop Robust Analytical Methods: Gain insights into the development of advanced analytical methods capable of precisely measuring individual mAb components in multi-component mAB cocktails within complex biological matrices.
Implement LC-MRM-MS Techniques for biologics: Understand the principles and applications of liquid chromatography-multiple reaction monitoring-mass spectrometry (LC-MRM-MS) combined with trypsin digestion for quantitative analysis of mAbs.
Understand Bioanalytical Method Validation per ICH M10 Guidelines: Learn the process and criteria for validating bioanalytical methods per ICH M10 Bioanalytical Method Validation Guidelines, including the use of surrogate matrices.
