Development of Quantitative Method for the Hydrolysis of Maleimide Linker on ADCs by LCMS/MS
- Implement a novel enzymatic digestion step coupled with LC-MS/MS analysis, to achieve highly selective and complete cleavage of the maleimide linker from the antibody framework providing an accurate and reliable measure DAR
- Utilize a stable isotope-labeled internal standard for the payload-linker fragment, to precisely normalize for variability in sample preparation and instrument response, ensuring superior precision and reproducibility of the hydrolysis data
- Automate the sample preparation workflow in a 96-well plate format, to significantly reduce error, enabling acceleration of high-throughput analysis