Biologics Formulation Strategy: Beyond Stability and Towards Development Design
Introduction After purification, a biologic drug substance may appear highly pure and well-characterized.However, purity alone does not guarantee stability. Even […]
CMC & Manufacturing
Explore CMC in biologics, including process development, formulation strategies, and drug product manufacturing.
Downstream Processing in Biologics: Process Flow and Development Strategy
Introduction Downstream processing (DSP) in biologics is the stage in manufacturing where the product is recovered, purified, and prepared for
Fed Batch vs Perfusion : Key Differences, Risks and Process Strategy
Introduction Fed batch vs perfusion is one of the most important decisions in biologics upstream process development. While multiple culture