From Process Development to GMP: Scaling with Pre-Packed Columns

In this episode of Chromatography Experts, Patrick Endres hosts Elena Kumm and Balu Guduri, as they discuss the challenges of moving from process development to GMP manufacturing and the growing demand for large-scale pre-packed chromatography columns.

Topics include:

• The challenges of scaling from development to manufacturing
• When column packing becomes a business and regulatory risk
• The performance data behind the SkillPak™ 1k MAX launch
• Chromatographic consistency, robustness, and reproducibility at 1 L scale
• The value of pre-packed columns compared to in-house or third-party packing
• Early customer feedback and what success looks like for manufacturing-scale chromatography

Whether you're involved in process development, scale-up, or downstream purification, this conversation provides valuable insights into reducing risk and improving confidence in manufacturing-ready chromatography solutions.