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

April 6, 2022

Webinar Overview

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

Speaker

Lieza Danan Leon, Ph.D., Co-Founder and CEO, LiVeritas BioSciences, Inc, South San Francisco, CA , USA

Lieza is a serial biotech entrepreneur in the SF Bay Area. Prior to her position as Co-founder and CEO of LiVeritas, she held scientific operations and strategic advisory leadership roles in the biopharma industry including the Co-Founder & CEO/COO/CSO at InterVenn and mass spec function lead to biotech startups (Stemcentrx and Sutro Biopharma). Lieza holds a Ph.D. in Biological Chemistry from UC Davis and a B.S. in Chemistry from the Ateneo De Manila University.

Na Pi Parra, Ph.D., Co-Founder and EVP of Marketing and Project Management, LiVeritas BioSciences, Inc, South San Francisco, CA , USA

Na is a senior leader in biotech in the SF Bay Area. Prior to her position as Co-founder and EVP of Marketing at LiVeritas, Na spent >15 years in product marketing and commercialization of scientific instrumentation with recent roles as the Senior Director of Marketing at Newomics and the US Western Regional Manager of Life Science and Mass Spectrometry at Bruker. Na holds a Ph.D. in Analytical Chemistry from UC Berkeley and a B.S. in Chemistry from Nanjing University.

 

For Research Use Only. Not for use in clinical diagnostic procedures.