Chromatographic purification is a key part of most biopharmaceutical downstream processes. Column chromatography helps separate biologic impurities like host-cell proteins (HCPs), oligomers, and nucleic acids from a target biologic. Biological separation often requires medium to high salt concentrations and faces the inherent risk of microbial contamination during water-based process streams.Industrial chromatography
Large-scale bio-chromatographic separation requires specifically designed equipment like industrial chromatography columns. Separation of compounds occurs in columns, and it’s critical to choose the right empty column and pack it expertly with the chromatography resin of choice. When performing large-scale chromatography on automated chromatography systems, consider:
- Scale of operation – choose a column platform that’s scalable. Lab-scale columns are often used for process development.
- Type of media or resin.
- Chromatography media lifetime.
- Maximum allowed process cycle times.
- Process steps.
- Recovery yield of target product.
Evaluating these parameters helps you determine the choice of column technology, column design, and material. The Purify app from Cytiva can guide you through the process for selecting chromatography columns and resins. Though prepacked chromatography columns are valuable options for some cases, reusable industrial chromatography columns can be an economical alternative. There is a wide range of column design options for good manufacturing practices (GMP) production.
Industrial chromatography column FAQs
Here are answers to some frequently asked questions about industrial chromatography columns, sometimes called process-scale columns:What is process-scale chromatography?
Process-scale chromatography refers to large-scale separation of biomolecules to produce biotherapeutics, such as recombinant proteins such as monoclonal antibodies and insulin.What are chromatography columns made of?
Chromatography columns come in borosilicate glass, acrylic, or stainless steel. They range in size from a few millimeters in diameter for lab scale to more than two meters for process-scale columns.What processes are industrial chromatography columns used for?
These process-scale columns are commonly used to characterize, purify, and manufacture various products in the biopharmaceutical industry.How can you streamline an industrial chromatography process?
In process-scale chromatography, industrial chromatography columns may measure two meters or more and often use pack-in-place technology in closed systems. Using a closed system in GMP environments helps to avoid contamination and streamlines efficiency.How do you pack process-scale columns?
A well-packed homogenous column bed provides the best separation results. Although details may vary, the common principle involved in process-scale column packing is to ensure that you consolidate media so it’s homogeneous. This helps reduce lot-to-lot variations and optimizes bed stability. Assemble and pack your column in the same room where you plan to run it. Automated axial compression packing supports situations that require rapid and reproducible packing.
Columns must be properly packed and qualified. Column efficiency testing is an important part of the qualification prior to use.