AmberChrom HPS60

Summary

Product identification

• Product Name: AMBERCHROM™ HPS60 Chromatography Resin
• Type: Monodispersed polymethacrylate strong cation exchange resin

Media Characteristics

• Description: Crosslinked polymethacrylate (semi-rigid), monodispersed resin beads
• Particle Size: 58 µm
• Ligand: Sulfonic acid functional group, an "S" type strong cation exchanger
• Ion exchange capacities: 210 – 300 µmol/mL

Operating limits

• Maximum Operating Temperature: 4 – 30°C
• pH Stability Range: pH 1 – 13
• Operating Buffers: Stable to all common buffers; including 1 M NaOH, 70% Ethanol
• Regeneration: 1 – 2 M NaCl
• Sanitization: 0.1 – 0.5 M NaOH

Feed water

• Storage Conditions: Packaged in 20% ethanol as 50% slurry. Store between 4°C and 30°C. Do not freeze.

Product water

AMBERCHROM™ HPS60 Chromatography Resin is designed for protein and mAb manufacturing, offering superior resolution of closely related impurities like fragments and aggregates, and improved removal of aggregates. It allows for direct loading of feedstreams due to an increased pH and conductivity range, eliminating the need for dilution holding tanks.

Mechanical / hydraulic

• Bed Heights: Can be packed to higher bed heights (up to 30 cm) compared to traditional agarose beads (typically max 20 cm) due to bead rigidity.
• Flowrates:
  • 400 cm/h at 30-cm bed height with reasonable operating pressures of 30 psi.
  • 600 cm/h at 20-cm bed height.
• Pressure Flow Properties:
  • Tested using a 40-cm diameter QuikScale® column.
  • Flow packed at 600 cm/h using RO water with 50-mM sodium chloride at room temperature.
  • Salt pulse experiments demonstrated adequate HETP and asymmetry for both 20-cm and 30-cm bed height packing.
  • Typical flowrate at 30 psi in a 40-cm diameter column:
    • 20-cm bed height: 600 cm/h
    • 30-cm bed height: 400 cm/h

Electrical

Not specified in the extract.

Ordering Information

• AMBERCHROM™ HPS60 100 mL Media: For Bench-top Packing and Process Development. Catalog No. 00011007652
• AMBERCHROM™ HPS60 1000 mL Media: For Packing and Scaling Trials. Catalog No. 00011007787
• AMBERCHROM™ HPS60 5 L Media: For Small-scale Manufacturing. Catalog No. 00011007789
• AMBERCHROM™ HPS60 50 L Media: For Large-scale Manufacturing. Catalog No. 00010366195

Regulatory Compliance and Supporting Documentation

• Manufacturing: Manufactured in a facility that adheres to Good Manufacturing Practices. Quality Management System approved to ISO® 9001.
• Documentation: Includes Validation Guide, Certificates of Quality, and User Guides.
• Animal Origin: All component materials are either animal free or in compliance with EMEA/410/01.

Disclaimer

This extraction may miss figures, footnotes, or revisions. Contractual data must match the OEM PDF revision used on the project.

Official datasheet (PDF)

Lenntech datasheet mirror