Process Characterization Kit
Resin kit for developing a robust, predictable, and scalable downstream chromatography process.
Chromatography technique
Overview
The Process Characterization Kit is a tool for gaining deeper chromatography process understanding. The kit allows you to study the potential impact that resin ligand density might have on the process outcome.
- Get critical insights on resin variation within ligand density specification interval.
- Develop a solid control strategy to obtain a robust, and scalable downstream chromatography process.
- Consists of three 25 mL bottles with different ligand densities, representing a low, average, and high value in the manufacturing envelope.
- Available for multiple resins from the Capto family, supporting the following techniques: ion exchange chromatography (IEX), hydrophobic interaction chromatography (HIC), and multimodal chromatography (MMC).
Process Characterization Kit overview
Chromatography resins are always produced against a specification interval. The Process Characterization Kit is designed to display this variation.
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:
Multimodal chromatography resins:
Hydrophobic interaction chromatography resins:
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.
