Targeted therapeutics, including antibody-drug conjugates (ADCs) and polymer-drug conjugates, represent a growing segment of therapeutic molecules in development. ADCs combine the targeting specificity of monoclonal antibodies (mAbs) with the highly potent cytotoxic properties of small molecules for the treatment of cancer. For ADCs, the cytotoxic payload is attached to the mAb via a covalent linkage; however, despite advances in protein engineering, the resultant conjugate is highly heterogeneous. The intrinsic heterogeneity significantly affects the complexity of the discovery and development pathway. Because Pace has extensive expertise in the development of both small molecules and biologics, the Pace Life Sciences Boston, MA team possesses extraordinary experience and capabilities in the development of ADCs and other polymer-drug conjugates.
Antibody-drug conjugates (ADCs) are a novel class of drugs that combine the potency of small molecule drugs with the targeting capabilities of highly-specific antibodies. While there is a wide array of different biochemical methods used for making ADCs, each method can have a varying effect on the stability of these types of therapeutics. In addition, the production of antibodies can be inherently complex and heterogeneous. Together, these challenges present a significant barrier to companies engaging in ADC drug development.
A novel ADC case study will be presented to highlight development success.
In this webinar you will learn:
- ADC analytical characterization techniques and current regulatory expectations
- Alternative approaches to quantitate ADC DAR.
- Optimizing bench-scale conjugation.
Who should attend:
Analytical Development Pharmaceutical Development Process Development Formulation Development
Speaker: Benjamin Buer, Ph.D.
Associate Director of Pharmaceutical Development