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

This presentation outlines a comprehensive, data-driven strategy for evaluating the developability of biologic therapeutics during the critical pre-formulation stage of development. Designed to support informed decision-making early in the pipeline, the workflow enables rapid identification of potential stability, manufacturability, and formulation risks, helping teams prioritize promising candidates and reduce downstream development challenges.

Through an in-depth monoclonal antibody case study, attendees will gain practical insight into how integrated developability assessments can accelerate candidate progression while improving overall formulation readiness. The presentation highlights a range of analytical and biophysical techniques used to characterize both colloidal and conformational stability, providing a detailed understanding of factors that influence aggregation propensity, structural integrity, and long-term product performance.

Key topics include the application of forced degradation studies to evaluate molecular resilience under thermal, oxidative, mechanical, and pH-related stress conditions, as well as the use of design of experiments (DoE) methodologies to efficiently screen and optimize formulation parameters across diverse excipient systems. By combining predictive stability modeling with empirical stress testing, the approach delivers a robust framework for identifying optimal formulation conditions with greater speed and confidence.

Viewers will also learn how integrating advanced analytics, statistical modeling, and systematic screening strategies can improve development efficiency, enhance product stability profiles, and support smoother transition into downstream process and clinical development stages. This presentation provides valuable insight for scientists and formulation teams seeking to establish scalable, risk-mitigated workflows for modern biologic therapeutics.