Process Characterization Kit

• Cat#No#: Pr-428C
• Product 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).
• Description: The Process Characterization Kit is a tool for gaining deeper process understanding. The kit consists of three bottles of the same chromatography resin. Each bottle has a defined ligand density level (high, average, low), which enables studies of the potential impact that this critical material attribute (CMA) might have on the process outcome.
• Characteristic: Study the potential impact of resin ligand density on product quality and process performance.
  Get critical insights on resin variation within a ligand density specification interval.
  Develop a solid control strategy to obtain a robust, and scalable downstream chromatography process.
• Matrix: High-flow agarose
• Average particle size: ~ 40 μm
• Ligand: Multimodal strong anion exchanger
• Ligand density: 0.08–0.11 mmol Cl-/mL resin
• Storage: 4°C to 30°C, 20% ethanol
• Pack size: 3 × 25 mL