Downstream Purification: Improving Scalability with Bio-Rad's New Chromatography Resins

Bio-Rad adds Nuvia ion exchange and mixed-mode resins to its GMP-ready Foresight Pro prepacked column line for downstream bioprocessing

Written bySharon Dong
| 4 min read
Foreground view of white prepacked chromatography columns on a stainless steel cart, with two fully gowned technicians operating equipment inside a sterile GMP cleanroom behind them.
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Bio-Rad Laboratories has expanded its Foresight Pro prepacked column line to include Nuvia ion exchange and mixed-mode resins, giving biopharma downstream processing teams a single-vendor option for process scale chromatography across cation exchange, anion exchange, and mixed-mode separation modes. The announcement closes a gap that forced teams already running Bio-Rad resins at lab scale to source GMP-ready prepacked columns from a third-party packer.

Editor's Note: Labs mid-cycle on a downstream process development program will find the timing here commercially significant. Until now, teams using Nuvia resins at development scale faced a procurement split, with Bio-Rad resin sourced from one vendor and prepacked columns from another, carrying attendant batch-blending risk and divided accountability. This launch collapses that structure for labs actively qualifying or scaling a Nuvia-based process, and it arrives ahead of Bio-Rad's planned 20–45 cm inner diameter (ID) column availability in early 2027, giving procurement teams a concrete decision point on whether to wait for larger column sizes or begin validation on the current range.

Five Nuvia resins now available in prepacked process scale chromatography columns

The expanded Foresight Pro line now includes prepacked columns with five Nuvia resin options:

  • Nuvia Q Media: strong anion exchanger (AEX)
  • Nuvia HP-Q Media: high-performance AEX
  • Nuvia HR-S Media: strong cation exchanger (CEX)
  • Nuvia cPrime Media: CEX-hydrophobic interaction chromatography (HIC) mixed-mode resin
  • Nuvia aPrime 4A Media: AEX-HIC mixed-mode resin

Bio-Rad currently ships columns with IDs of 5–13 cm and bed heights of 10 or 20 cm; larger columns spanning 20–45 cm ID are in development, with availability targeted for early 2027.

Bio-Rad manufactures all Foresight Pro columns in a controlled ISO Class 7 cleanroom and ships them as good manufacturing practice (GMP) ready. Wetted parts meet the USP Class VI requirements of USP <88> Biological Reactivity Tests, In Vivo, and standard Tri-Clamp connections allow direct integration with existing downstream process equipment.

Bio-Rad engineers the Nuvia beads for fast mass transfer, chemical and mechanical stability across a wide pH and salt range, and minimal non-specific binding; dynamic binding capacity holds consistent across a broad range of flow rates, which matters for teams scaling methods from bench to pilot to production without reoptimizing loading conditions at each stage. Base bead chemistry differs by resin: Nuvia Q, HR-S, cPrime, and aPrime 4A use polyacrylamide or polyacrylamide-derived matrices, while Nuvia HP-Q uses Bio-Rad's UNOsphere epoxide base bead, suited for high-flow purification of large biomolecules such as IgM, viruses, and virus-like particles (VLPs).

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Does single-lot packing set these process scale chromatography columns apart?

Bio-Rad packs each Foresight Pro column exclusively from a single production lot, which eliminates within-column batch variability and allows one certificate of analysis to cover the entire packed column. Third-party suppliers packing Bio-Rad resins into their own hardware may combine multiple resin batches during packing, introducing lot-to-lot variability that demands additional analytical justification in the regulatory file.

"The new Nuvia prepacked Foresight Pro chromatography columns build on the strong market response to our original CHT Ceramic Hydroxyapatite Media columns, which launched in 2022," said Diab Elmashni, Director, Process Chromatography Business at Bio-Rad Laboratories. "Customers asked us for column options built around different resins, and this line is our response. What sets these columns apart is that each one is packed using media from a single production lot, instead of blending multiple resin batches together during packing. That single-lot approach is what makes our Foresight Pro Columns a genuinely unique, single-source offering, providing biopharma customers with superior technical, application, and product support."

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For process development scientists and lab managers overseeing method validation, single-lot packing simplifies process scale chromatography documentation: a single certificate of analysis covers the full packed bed, and the need to reconcile multiple resin lot certificates disappears. The practical tradeoff is supply chain dependency; teams that commit to Foresight Pro columns must rely on Bio-Rad's resin lot availability and cannot independently source resin for repacking.

FactorForesight Pro prepacked columnsCustomer-packed columns
Resin sourcingSingle lot per column, Bio-Rad sourcedCustomer-sourced; may blend multiple lots during packing
Packing quality controlManufacturer-verified (height equivalent to a theoretical plate [HETP], asymmetry, endotoxin, bioburden)Customer-validated; repeatability depends on internal packing capability
GMP documentation packageIncluded; regulatory support file availableCustomer-generated; requires in-house protocol
USP <88> complianceConfirmed by manufacturerCustomer responsibility to verify wetted parts
Column diameter availability (current)5–13 cm IDFlexible; any commercially available hardware
Large-scale availability20–45 cm ID targeted early 2027Available now from third-party hardware suppliers
Vendor accountabilitySingle relationship: resin, column, and supportSplit between resin supplier and column packer

Prepacked process scale chromatography columns reduce qualification burden for lean downstream teams

Sourcing prepacked columns from the resin manufacturer consolidates two qualification steps, resin lot release and column packing verification, into one certified package, cutting the number of in-house GMP protocols a lab manager must own and maintain. In-house column packing demands specialized equipment, trained personnel, and documented procedures that validation requires; for labs running lean teams or scaling novel modalities, moving that work to Bio-Rad frees capacity for method development and process validation that stays in-house regardless. The Nuvia columns follow the same hardware format, Tri-Clamp connections, and regulatory support file structure already established by the CHT Foresight Pro columns Bio-Rad launched in 2022, so teams familiar with that product face a shorter requalification path.

Contract development and manufacturing organizations (CDMOs) running multi-client downstream platforms gain a specific benefit: resin procurement, column qualification, and technical support all route through one vendor relationship rather than two, reducing the supplier qualification overhead a CDMO carries under the ICH Q10 pharmaceutical quality system framework. That framework requires active management of supplier qualification and supply chain continuity, and consolidation cuts the number of qualified suppliers a CDMO must track for each resin type.

In facilities that pair single-use bioprocessing equipment with conventional chromatography, the Foresight Pro column occupies the reusable resin-based purification step in the downstream train. Lab managers scoping total procurement complexity should factor in column requalification scheduling, cleaning validation obligations under FDA ICH Q7 GMP guidance, and lead time exposure from dependence on Bio-Rad's supply chain for both resin and packed columns.

What the Nuvia Foresight Pro expansion means for downstream procurement decisions

Bio-Rad's move into Nuvia prepacked columns closes a procurement gap that pushed development-scale Nuvia users toward split-vendor arrangements, and the single-lot packing model gives those teams a straightforward path to a unified certificate of analysis structure across their regulatory file. The 5–13 cm ID range covers process development and clinical manufacturing well, but limits utility for large-scale commercial runs until the 20–45 cm columns reach availability in early 2027. Lab managers weighing this launch should set simplified vendor accountability and GMP documentation against supply chain dependency; that tradeoff maps most clearly against their program's current scale and timeline.

This content includes text that has been generated with the assistance of AI. For more information, view Lab Manager's AI use policy.

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About the Author

  • asian woman in a malaysian-chinese batik shirt with glasses, smiling

    Sharon Dong, MSc, BSc (Hons), joined LabX Media Group (LMG) in 2026 as a Product News & Intelligence Editor. She has a strong background in cellular biology, microbiology, immunology, and molecular genetics. She is an experienced science education and outreach facilitator. Sharon is passionate about communicating science in ways that are clear, engaging, and accessible to a broad audience. In her free time, she enjoys solving jigsaw puzzles and cooking. Sharon can be reached at sdong@labx.com.

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