Foresight™ Pro Chromatography Columns, Nuvia™ Ion Exchange Media

Foresight Pro Nuvia Ion Exchange Prepacked Columns are good manufacturing practice (GMP) ready and specifically designed for biopharmaceutical purification workflows. Prepacked with high-capacity ion exchange resins built on robust physical properties and optimized chemistries, these columns deliver exceptional purification productivity and resolution for the capture and polishing of biosimilars and biotherapeutics.

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Overview

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 Ion Exchange Applications and Uses

Nuvia HR-S Media

High-resolution polishing of monoclonal antibodies (mAbs)
Separation of closely related biomolecules and charge variants
Intermediate and final polishing steps for biotherapeutics
Aggregate removal in polishing workflows
Host cell protein (HCP) clearance
Separation of biosimilar charge variants

Nuvia Q Media

Capture and polishing of biosimilars and biotherapeutics
High-capacity anion exchange purification of recombinant proteins
Flow-through polishing for mAb purification
DNA and endotoxin clearance
HCP removal
Virus clearance in downstream bioprocessing
Process development with wide pH and flow rate working ranges

Nuvia HP-Q Media

Purification of high molecular weight (HMW) plasma proteins, including IgA and IgM
Virus and virus-like particle (VLP) purification
Purification of PEGylated proteins
Vaccine purification and polishing
Large biomolecule capture and polishing
HCP and impurity clearance

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.

Graph Evaluation of N/m and A, comparing pre- and post-ISTA tests. — **Fig. 1. Evaluation of N/m and A_s, comparing pre- and post-ISTA tests.** A, evaluation of N/m; B, evaluation of A_s. Pre-ISTA test (■); post-ISTA test (■). A_s, 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.

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.

Graph Evaluation of A, comparing the first and tenth cycles of Foresight Pro Columns — **Fig. 3. Evaluation of A_s, comparing the first and tenth cycles of Foresight Pro Columns** First cycle (■); tenth cycle (■). A_s, asymmetry factor; ID, inner diameter.

Figure 4 shows the linear relationship between pressure and flow rate for Foresight Pro Columns packed with Nuvia Ion Exchange Media. The data indicate that column pressure remains below 3 bar at the operating linear velocity of 150 cm/hr for the Foresight Pro Nuvia HR-S Column.

**Fig. 4. Pressure/flow performance of Foresight Pro Column.** Foresight Pro Column, Nuvia HR-S Media (1.0 L, 8 cm ID x 20 cm length).

Non-Product Contact Material Summary

Element	Material
Top and bottom supporting plates	Polypropylene
Holding bars	Polyamide or 304 stainless steel

Product Contact Material Summary

Element	Material	USP <88> Class	CFR 21 177	Animal Origin
Column body	Glass (5 cm ID columns)	N/A	N/A	N/A
Column body	Acrylic (8, 10, 13 cm ID columns)	Class VI	177.1010	Animal-free
Flow distributors	Polypropylene	Class VI	177.1520	Animal-free
Inlet and outlet connectors	Polypropylene	Class VI	177.1520	Animal-free
Tubing connections	Reinforced elastomer tubing	Class VI	177.2600	Animal-free
Tri-Clamp Gasket and O-rings	Ethylene propylene diene monomer (EPDM)	Class VI	177.2600	Animal-free
Bed support screens	Polyamide	Class VI	177.1500	Animal-free

Related Categories

Nuvia Ion Exchange Resins
Foresight Pro Chromatography Columns, Nuvia Mixed-Mode 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 HR-S: Column efficiency, plates/meter

>4,200

Nuvia HR-S: Column asymmetry

0.80 ≤ As ≤ 2.2

Nuvia HR-S Column shipping solution

20% ethanol + 0.1 M NaCl

Nuvia HP-Q: Column efficiency, plates/meter

>4,200

Nuvia HP-Q: Column asymmetry

0.80 ≤ As ≤ 1.8

Nuvia HP-Q Column shipping solution

20% ethanol

Nuvia Q: Column efficiency, plates/meter

>2,500

Nuvia Q: Column asymmetry