Lidiia Tsvik, PhD, is a Scientist in Manufacturing Science and Technology at Novartis Austria, specializing in downstream process development and characterization. Expertise spans scale-down model development, chromatography, virus filtration, process characterization, and technology transfer for biopharmaceutical manufacturing. Prior to joining industry, four years of academic research focused on protein discovery and engineering, resulting in several scientific publications and co-inventorship of a patent related to enzyme-based analytical methods.
Downstream process (DSP) robustness depends on more than a successful purification sequence. As feedstream composition, impurity profiles, analytical capabilities, manufacturing conditions, and product attributes evolve, the purification challenge itself can change. This presentation explores the scientific foundations of robust DSP, including mechanistic understanding of product and impurity properties, orthogonal separation strategies, platform process assumptions, representative scale-down models, and process monitoring. Illustrative case studies will highlight how seemingly minor changes can challenge established control strategies and why robust DSP must continuously adapt to evolving process knowledge and manufacturing realities. The presentation will emphasize robust DSP as a living control strategy built on scientific understanding, monitoring, and continuous learning.