Beyond the Acronyms: What Today's Trials Really Need From RTSM

Chromatography remains the cornerstone of biologics purification, ensuring product quality and regulatory compliance in an increasingly complex manufacturing landscape. From monoclonal antibodies to advanced cell and gene therapies, the choice of resin and system configuration directly impacts yield, purity, and scalability. Understanding the science behind resin interactions — such as ion exchange, affinity, and hydrophobic mechanisms — enables process engineers to optimize separation efficiency while minimizing cost and cycle time. Equally critical is system qualification, which validates performance under GMP conditions and safeguards consistency across global production sites.

As biologics pipelines expand, chromatography strategies must evolve to address higher titers, diverse molecular structures, and stringent regulatory expectations. Explore how resin selection, process design, and qualification protocols converge to create robust purification workflows that meet both scientific and operational demands.

Access the full blog to learn best practices for chromatography in biologics manufacturing.