From Molecule to Formulation: A Systematic Approach to Assess Biologics Developability

Explore a real-world case study on developability and formulation assessment to learn the application and impact of key techniques, and see how a systematic, data-driven approach can streamline your biologics developability and formulation decisions.

Register Free: https://www.pharmtech.com/pt_w/biologics

Event Overview:

This presentation introduces a systematic, data-driven approach for assessing the developability of biologic therapeutics, with a focus on pre-formulation development. The workflow is designed to facilitate early risk identification and streamline the advancement of candidates through the development pipeline. A case study featuring a monoclonal antibody illustrates the application and impact of key developability assessment techniques. These include in silico profiling of colloidal and conformational stability, forced degradation studies, and formulation screening using design of experiments (DoE). The integration of predictive stability modeling and empirical stress testing across diverse excipient systems highlights the robustness and efficiency of the approach.

Key Learning Objectives:

• Assess biologics developability using predictive and empirical tools
• Understand the impact of in silico profiling, forced degradation, and formulation screening
• Learn how to integrate modeling and stress data for informed formulation choices

Who Should Attend:

• Any individual involved in the analysis, development, manufacturing, and quality control of biopharmaceutical products

Speaker

John Rockwell
Manager BioAnalytics
Catalent

John Rockwell is a scientific manager at Catalent in the BioAnalytics department. In his role, he leads a biologics analytical team that specializes in formulation development, analytical method development, and characterization. He received his BSc in Biochemistry from Rutgers University in 2006 and has dedicated his career to analytical characterization and formulation development for biologics. With nearly two decades of experience, he provides strategic and technical leadership in advancing biologics developability and pre-formulation strategies.

Register Free: https://www.pharmtech.com/pt_w/biologics