Nuvia wPrime 2A Media

Nuvia wPrime 2A resin is able to be scaled up for downstream bioprocessing at pilot and manufacturing scales. This chromatography resin can help achieve high product yield and purity, and improve process economics and productivity.

Superior Selectivity

Traditional single-mode strong anion exchange resins, such as Nuvia Q and Nuvia HP-Q resins, and multimodal resins with a strong anion exchange component, such as Nuvia aPrime 4A Media, have a quaternary amine that is always positively charged regardless of the pH. The ion exchange component of Nuvia wPrime 2A chromatography resin consists of a secondary amine and functions as a weak anion exchanger in a similar manner as the traditional single-mode weak anion exchange resin such as Macro-Prep DEAE Resin. The charge state of Nuvia wPrime 2A resin can be modulated between pH 6.4, where more than 90% of the resin is charged, and pH 8.4, where less than 10% of the resin is charged.

Adjusting the mobile phase (buffer) pH allows the resin to be tuned for specific needs. For example, a target can be adsorbed to the resin (e.g. the target will adhere to the chromatography resin) in bind-and-elute (B/E) mode and then eluted by adjusting the buffer pH and/or the ionic strength (salt concentration). The weaker AEX interactions are conducive to milder elution conditions compared to when using a strong AEX resin. In addition to being used in a bind/elute workflow, this chromatography media can be used in flowthrough (FT) mode to allow the target to flow-through the resin and for the resin to capture impurities. Depending on the properties of the target and the contaminants, Nuvia wPrime 2A resin can be used to remove various impurities, including host cell proteins (HCP), low molecular weight (LWM) and high molecular weight (HWM) aggregates, dimers, antibody charge variants, and Protein A leachates.

Nuvia wPrime 2A Media can be used in the purification of both established therapeutics, such as monoclonal antibody (mAb), bispecific antibody (bsAb), protein, and virus-based therapies including adeno-associated virus (AAV) therapies, as well as diverse new constructs in development, including those that lack affinity handles and/or have an isoelectric point (pI) that is close to the pI of an unwanted molecule. Nuvia wPrime 2A chromatography resin fits in any step of the purification workflow.

Reliable and Resilient

Nuvia wPrime 2A Media is built upon polyacrylamide Nuvia bead technology. Nuvia resins are chemically and mechanically stable and are integral to existing commercialized biotherapies. The bead size is optimized for fast mass transfer dynamics to achieve process-scale purification of biomolecules at high flow rates without being limited by column pressure. Nuvia wPrime 2A chromatography resin is built to have superior mechanical strength and optimized pore structure to ensure that the high dynamic binding capacity (DBC) is maintained at the high flow rates required for process purification, which is essential for the productivity needed in downstream manufacturing. The chemical stability of the resin allows it to consistently perform with minimal changes to DBC or recovery even after multiple exposures to sodium hydroxide (NaOH).  

Features and Benefits

• Nuvia wPrime 2A Media can be scaled up for industrial production
• The resin is multimodal: electrostatic and/or hydrophobic interaction (HIC) may be used for purification
• The anion-exchange (AEX) mode strength can be adjusted to meet specific requirements, offering a flexible design space for developing methods that achieve both high yields and purity simultaneously
• Multiple modes of interaction (AEX and HIC) allow for different selectivity compared to other multimodal resins
• The resin allows for elution conditions that can be of a milder salt concentration and/or pH than those needed from strong AEX resins, which may help minimize target aggregation
• The optimal balance between the interaction modalities provides simultaneous high purity and yield during both B/E and FT purifications
• Nuvia wPrime 2A Media exhibits high chemical and mechanical stability that does not exhibit significant changes in performance after multiple uses and NaOH cleanings and, as such, can provide cost efficiency over multiple cycles
• Like other mixed-mode resins, Nuvia wPrime 2A resin can be used for process intensification to reduce the number of chromatography and purification workflow steps, improving process economics by reducing processing time and waste, as well as material, labor, and operating costs
• The use of Nuvia wPrime 2A chromatography resin’s multiple modes of interaction to reduce two downstream chromatographic steps into a single step can help achieve sustainability goals by reducing a process’s water and energy needs
• The resin meets industrial demands for robust performance, regulatory support, and security of supply
• Bio-Rad has been a trusted supplier of chromatography resins since 1952; resins are manufactured with quality management system controls and a certificate of analysis for each batch/lot is available

Applications and Uses

• Purification of biopharmaceutical molecules, including but not limited to: monoclonal antibodies (mAbs) including IgGs, bispecific antibodies (bsAbs), adeno-associated viruses (AAVs), native proteins and recombinant proteins
• Purification of molecules including biotherapies that adhere too tightly to strong anion exchange resins; targets that adsorb too strongly to a resin may not elute, resulting in low yields
• Separation of mixtures that may be challenging to purify, such as proteins with similar isoelectric points (pIs)
• Removal of impurities from expression cells, such as host cell proteins (HCPs) and nucleic acids such as host cell DNA (HCDNA)
• Removal of target contaminants, such as dimers, low-molecular weight aggregates (LWMs), high-molecular weight aggregates (HMWs), and acidic/basic charge variants
• Enrichment of full AAV capsids by separating empty from full capsids
• Removal of process-related contaminants, such as leached Protein A from antibody capture chromatography, as a second mAb/bsAb workflow step
• Binding of target molecules (bind-elute mode) or of impurities (flow through mode) as a capture, intermediate, or a polishing step
• Process intensification by combining two chromatographic steps with separate single-mode separate into a single step with one mixed-mode resin