Platform Analytical Strategies that Expedite ADCs to IND and Beyond

A critical step in the development process for an antibody-drug conjugate (ADC) is establishing scientifically sound analytical methods that measure key product quality attributes to support pre-clinical activities and downstream clinical release and stability testing.

The application of platform analytical methods to support testing of early phase biologics enables expedited paths to IND by removing analytical method development from critical path. Structural conservation within commonly investigated immunoglobulin subclasses allows for the approach to be de-risked when a platform method has been previously validated with a standard of sufficient similarity to the molecule under test. Structural variability of small molecule linker payloads and their impact on the physicochemical properties of the protein intermediate post conjugation, necessitates a more involved strategic approach to enable use of platform methods for antibody-drug conjugates (ADCs).

Join Abzena’s Senior Scientific Leader for Analytical Development, Dr Eric Miller for a complimentary lunch seminar focused on analytical strategies that can help you quickly achieve your IND milestone. Learn how Abzena is leveraging its laboratory methods, development data, and method qualification results, to standardize an automated process that predicts how certain antibody molecules will behave, based on a structural assessment. Using case studies, we will demonstrate how these strategies can reduce risk, minimize costs, and accelerate your ADCs development timeline.

Key topics covered include:

• Outlining the importance of platform analytical strategies
• Justification of application of platform analytical strategies to IgGs
• Challenges with the application of platform analytical strategies to ADCs
• Sharing lessons learned from IgGs and the application of platform strategies to ADCs

About the speaker:

Dr Eric Miller is the Senior Scientific Project Leader for Analytical Development at Abzena. With over 20 years of pharmaceutical industry expertise, he has held analytical and quality control leadership roles for companies in the antibody-drug conjugate (ADCs), biologics, and cell & gene therapy space.  Eric received his BASc. in Biology from the UCSB and his PhD in Chemistry from UCSD.