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

Chromatography continues to be a foundational technique for purifying biologics, playing a vital role in maintaining product quality and meeting regulatory expectations in today’s increasingly complex manufacturing environment. Whether working with monoclonal antibodies or next-generation cell and gene therapies, decisions around resin selection and system setup have a direct influence on purity, recovery, and long-term scalability. A solid grasp of how different resins function — ion exchange, affinity, hydrophobic interactions, and more — helps process engineers fine-tune separation performance while controlling costs and shortening production cycles. Just as important is qualifying chromatography systems to ensure they perform reliably under GMP conditions and deliver consistent outcomes across global facilities.

As biologics pipelines grow and diversify, purification strategies must keep pace with rising titers, new molecular formats, and heightened regulatory scrutiny. This overview examines how resin choices, process architecture, and qualification practices work together to build resilient, efficient purification workflows that satisfy both operational and scientific requirements.

Read the full blog for detailed guidance on chromatography best practices in biologics manufacturing.