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Foresight™ Pro Chromatography Columns, Nuvia™ Mixed-Mode Media

Foresight™ Pro Chromatography Columns, Nuvia™ Mixed-Mode Media

Foresight Pro Nuvia Mixed-Mode Prepacked Columns are good manufacturing practice (GMP) ready and specifically designed for biopharmaceutical purification workflows. Available with Nuvia aPrime 4A Hydrophobic Anion Exchange Media (AEX-HIC) for a wide design space and high purity and yield, or Nuvia cPrime Hydrophobic Cation Exchange Media (CEX-HIC) for versatile capture and high recovery across a broad range of salt concentrations and pH.

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Overview

foresight pro chromatography 1

5–33 cm ID Columns

Foresight Pro Chromatography Columns are GMP ready columns specifically designed for use in all biopharmaceutical manufacturing applications. The columns have a sanitary design with minimal dead space and effective cleanability, and connections to pumping systems are made via standard 3/4" Tri-Clamp fittings.

Prepacked columns with Nuvia Media are available in a range of column diameters and bed heights. These columns are shipped in 20% ethanol and/or salt, as applicable to the resin. (See specification table.)

Prepacked Column Features and Benefits

  • GMP ready columns — validated and ready to use
  • Excellent performance — data include asymmetry, HETP, endotoxin, and bioburden
  • Robust column hardware design maintains a packed bed
  • Columns maintain performance criteria after shipping and cycling
  • All wetted parts meet USP Class VI requirements of USP <88>
  • Standard Tri-Clamp connections — plug and play
  • Columns are packed in a controlled ISO Class 7 cleanroom
  • Range of column diameters and bed heights — 5–13 cm ID and 10 or 20 cm bed heights
  • Resin reference sample included with each column
  • Regulatory support file available

Nuvia aPrime 4A Media Applications

  • Polishing of monoclonal antibodies (mAbs) in flow-through mode and capture mode
  • Host cell protein (HCP) removal
  • DNA and endotoxin clearance
  • Virus clearance and removal
  • Polishing of recombinant proteins
  • Aggregate removal

Nuvia cPrime Media Applications

  • Capture and polishing of mAbs
  • Recombinant protein purification
  • Biotherapeutic capture at high salt concentrations
  • Aggregate and charge variant removal
  • Post Protein A polishing steps
  • Process-scale purification of biotherapeutics across a wide pH range

Packing Quality

The performance of the Foresight Pro Columns was evaluated before and after International Safe Transit Association (ISTA) testing. As shown in Figure 1, the columns maintained performance criteria, indicating excellent stability during shipping.

Image
Graph Evaluation of N/m and Aₛ, comparing pre- and post-ISTA tests.
Fig. 1. Evaluation of N/m and As, comparing pre- and post-ISTA tests. A, evaluation of N/m; B, evaluation of As. Pre-ISTA test (■); post-ISTA test (■). As, asymmetry factor; ID, inner diameter; ISTA, International Safe Transit Association; N/m, number of theoretical plates per meter.

Cycling Data

The performance of the Foresight Pro Columns was evaluated for flow stability. The column went through a series of cycles. Figures 2 and 3 show that the columns maintained performance criteria, indicating a robust packed bed.

Image
Graph Evaluation of N/m, comparing the first and tenth cycles of Foresight Pro Columns.
Fig. 2. Evaluation of N/m, comparing the first and tenth cycles of Foresight Pro Columns. First cycle (■); tenth cycle (■). ID, inner diameter; N/m, number of theoretical plates per meter.
Image
Graph Evaluation of A, comparing the first and tenth cycles of Foresight Pro Columns.
Fig. 3. Evaluation of As, comparing the first and tenth cycles of Foresight Pro Columns First cycle (■); tenth cycle (■). As, asymmetry factor; ID, inner diameter.

Figure 4 shows the linear relationship between pressure and flow rate for Foresight Pro Columns packed with Nuvia Mixed-Mode Media. The data indicate that column pressure remains below 3 bar at the operating linear velocity of250 cm/hr for the Foresight Pro Nuvia cPrime Column.

Image
Graph Pressure/flow performance of Foresight Pro Column.
Fig. 4. Pressure/flow performance of Foresight Pro Column. Foresight Pro Column, Nuvia cPrime Media (1.0 L, 8 cm ID x 20 cm length).

Non-Product Contact Material Summary

ElementMaterial
Top and bottom supporting platesPolypropylene
Holding barsPolyamide or 304 stainless steel

Product Contact Material Summary

ElementMaterialUSP <88> ClassCFR 21 177Animal Origin
Column bodyGlass (5 cm ID columns)N/AN/AN/A
Column bodyAcrylic (8, 10, 13 cm ID columns)Class VI177.1010Animal-free
Flow distributorsPolypropyleneClass VI177.1520Animal-free
Inlet and outlet connectorsPolypropyleneClass VI177.1520Animal-free
Tubing connectionsReinforced elastomer tubingClass VI177.2600Animal-free
Tri-Clamp Gasket and O-ringsEthylene propylene diene monomer (EPDM)Class VI177.2600Animal-free
Bed support screensPolyamideClass VI177.1500Animal-free

Related Products

  • Nuvia cPrime Media
  • Nuvia aPrime 4A Media
  • Nuvia wPrime 2A Media

Related Categories

  • Nuvia Mixed-Mode Resins
  • Foresight Pro Chromatography Columns, Nuvia Ion Exchange Resins
  • Foresight Pro Chromatography Columns, CHT™ Resins
  • Foresight Prepacked Chromatography Filter Plates & Columns

Specifications

Microbial bioburden, CFU/ml
<10
Endotoxin level, EU/ml
<0.25
Nuvia cPrime: Column efficiency, plates/meter
>3,000
Nuvia cPrime: Column asymmetry
0.80 ≤ As ≤ 1.8
Nuvia cPrime Column shipping solution
20% ethanol + 30 mM sodium sulfite
Nuvia aPrime 4A: column efficiency, plates/meter
>4,200
Nuvia aPrime 4A: column asymmetry
0.80 ≤ As ≤ 1.8
Nuvia aPrime 4A shipping solution
20% ethanol + 1 M NaCl

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