The kit consists of three bottles with 25 mL of the same resin. Each of the bottles has a different ligand density, representing a low, average, and high value in the manufacturing envelope. In most cases the levels will be similar to the specification window (Fig 1).

For ion exchange resins, ligand density is measured as ion capacity. For hydrophobic interaction resins, it is measured as retention time for a model protein.

Fig 1. The target ligand densities in a Process Characterization Kit printed over the manufacturing envelope.

Resins available in the Process Characterization Kit format

 
Cation exchange chromatography resins:

• Capto S ImpAct
• Capto SP ImpRes

Multimodal chromatography resins:

• Capto MMC
• Capto MMC ImpRes
• Capto adhere
• Capto adhere ImpRes

Hydrophobic interaction chromatography resins:

• Capto Phenyl (high sub)
• Capto Phenyl ImpRes
• Capto Butyl ImpRes

The growing need for deeper process understanding

 
With the increased molecular diversity and drive for higher productivity, the challenge of getting deeper understanding for sources of variability and set mitigation strategies grows.

Over the past decade, using a quality by design (QbD) approach to biopharmaceutical process development has helped ensure patient safety and drug efficacy. QbD incorporates the identification of critical quality attributes (CQAs) and links to critical process parameters (CPPs) and critical material attributes (CMAs).

Chromatography resin properties are sometimes suggested as CMAs that potentially could impact CQAs. The properties are also considered important parameters for consistent downstream chromatography process performance.

A chromatography resin is made of a base matrix (porous particle) with a specific ligand added at a desired concentration to achieve its intended function. Studying the potential impact of ligand density variability provides invaluable information for developing strategies to ensure robust process performance.

Access insights and recommendations for developing robust purification processes for biopharmaceuticals.