Phase Appropriate LC-MS Strategy for the Rapid Characterization of Bispecific Antibodies

Throughout the preclinical drug development process, high-quality liquid chromatography-mass spectrometry (LC-MS) data fosters actionable insights. The pioneers of accelerated drug development have adapted MS-based strategies for early identification and monitoring of drug candidate’s presumptive Critical Quality Attributes (pCQA). Accurate compound and process characterization enables faster development, increasing probability of success in human clinical trials.

• Rapid, ultra-high resolution coupled with isotopic fidelity for intact mass analysis workflows offer delta masses as basis for screening pCQAs with high confidence. These workflows deliver phase appropriate speed in place of time-consuming peptide map workflows.
  
• Intact mass data sets generated from reduced or non-reduced, glycosylated or deglycosylated samples in denaturing and/or native LC-MS conditions, offer a wealth of characterization insights for optimizing drug designs, developing manufacturing processes and other IND-enabling activities. 
• A case study looking at 100 s of unique Bispecific Antibody (BsAb) highlights how LiVeritas supported a biopharma partners’ urgent timelines and aggressive milestones. This MS-based characterization strategy is also applicable to phase appropriate gap analysis regulatory requirements for IND and BLA submission.

Key Learning Objectives:

• Which information beyond identity can be derived from intact mass analysis by LC-MS
• Methods for the characterization of heterogenous molecules such as bispecific antibodies
• End to end workflow considerations for intact mass analysis

Who Should Attend:

• Scientists involved in preclinical biologics characterization supporting clone screening, liability assessments or process development
• Lab and project managers involved in biologics development