Article: Streamlining Process Characterization Toward Successful Validation Campaigns
Summary: Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks. This article will identify and explain the various drivers for such process characterization and late-phase development, while offering a stepwise approach for the definition and execution of process characterization. It will also demonstrate how process characterization can often accelerate speed to market, having previously been tailored for different programs based on prior knowledge and experience.