BioResolve Columns

BioResolve Columns

Innovative solutions for mAb characterizations

Innovative solutions for mAb characterizations

Biological separation challenges are becoming more complex each day. BioResolve chemistry consumables provide innovative solutions for specific analytical challenges related to mAb-based and associated biotherapeutic drugs.

Waters BioResolve Columns include column chemistries that can be used on UPLC, UHPLC, and HPLC platforms with a relevant application-specific standard and superior out-of-the-box performance.

BioResolve columns for intact protein analysis, characterization, monitoring and QC of charge variants of mAbs and ADCs. BioResolve Columns
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Specifications

Overview

  • Achieve batch and column consistency for mAb separations
  • Reversed-phase solutions for intact and IdeS digested mAbs
  • Meet analysis requirements with a strong cation-exchange-based offering for mAb charge variant analyses and high pore volume, 200 Å SEC offering for mAb aggregates, monomers, and fragments analyses
  • Increase confidence in your data with flexible, reproducible, high resolution separations 
  • Increased lifetime without sacrificing performance with BioResolve Guards
  • Minimize band spread and enhance mAb separations with Cation-Exchange column technology 
  • Confirm column, system, and separation method performance with NIST-based Intact mAb standard, mAb Size Variant standard, and mAb Charge Variant standard 
  • Implement charge variant profiling easily with BioResolve CX pH buffer concentrates and IonHance CX-MS buffers for on-line IEX-MS analysis 

Recommended Use: For improved speed, sensitivity, and resolution in methods development.

BioResolve Column Featured Technologies

BioResolve Column Featured Technologies
VanGuard FIT*
  • All-in-one guard plus column design
  • Achieve longer column lifetimes
  • Easy installation

* Specific to columns noted with VanGuard FIT

BioResolve Column Characteristics

BioResolve Column Characteristics
BioResolve RP mAb Polyphenyl Columns
  • Improved peak capacity for better component resolution
  • Minimal injection-to-injection carryover for increased confidence of analyses
  • Ability to operate at lower temperatures for less on-column sample degradation
  • Ensured column-to-column performance by being quality control (QC) tested with a NIST-based, mAb subunit standard
  • LC system (HPLC, UHPLC, UPLC) agnostic, doesn’t compromise required separation performance
  • VanGuard FIT column option
BioResolve SCX mAb Columns
  • Ability to reliably separate, with accurate charge variant quantitation, a wide range of mAbs using optical or LC-MS compatible mobile phases
  • Excellent batch-to-batch and column-to-column performance consistency
  • LC system (HPLC, UHPLC, UPLC) agnostic, doesn’t compromise required separation performance
  • Ensured column-to-column performance by being QC tested with a NIST-based, mAb Charge Variant standard
  • VanGuard FIT column option
BioResolve SEC mAb Columns
  • Deliver reproducible, accurate quantitation of monoclonal antibodies (mAbs), associated high molecular weight aggregates (>300,000 Da), and lower molecular weight fragments (e.g., <100,000 Da)
  • Ensured column-to-column performance by being QC tested with the NIST-based, mAb size variant standard
  • Out-of-the-box performance
  • LC system (HPLC, UHPLC, UPLC) agnostic, doesn't compromise required separation performance

BioResolve Buffers and Concentrates

BioResolve Buffers and Concentrates
BioResolve CX pH Buffer Concentrates
  • pH gradient, system mobile phases for simple-to-implement charge variant profiling using optical detection only in combination with BioResolve SCX mAb, 3 μm columns
  • Carefully optimized pH 5.0 to 10.2 gradients for use with the cation-exchange column to achieve high resolution, robust separations
  • 100 mL 10x concentrates for the preparation of mobile phase using a simple 10-fold water dilution
IonHance CX-MS pH Buffer Concentrates
  • Specifically formulated for reproducible LC-MS analyses of Intact mAb and mAb IdeS digests used with BioResolve SCX mAb, 3um columns
  • Deliver cleaner spectra, significantly reduce non-desired noise, super charging, and ion suppression
  • Easy to use. Simply add high-quality, MS-grade water to the 100 mL 10x buffer concentrates that are shipped in 1 L MS-certified LDPE bottles to minimize buffer contamination

Reversed-Phase Solutions for Intact and IdeS Digested mAbs

Experience an innovative solution for the analytical characterization of intact protein analysis of mAbs and ADCs with BioResolve RP mAb Polyphenyl Columns. Utilizing a novel phenyl bonding, solid-core technology, these columns provide better resolution at higher flow rates, so you can maximize the resolving power and selectivity of various analyzed protein samples. The high coverage bonding prevents carryover effects and increases low pH stability for improved column lifetime.

Cation-Exchange Column Technology for Antibody Charge Variants

Charge variant analysis for monoclonal antibodies and other proteins is a critical quality attribute to understand. The BioResolve SCX mAb Columns offer a solution-based platform for LC and LC-MS users utilizing robust salt and pH gradient methods. The BioResolve SCX mAb Columns are based on non-porous, 3 μm particle technology for optimal protein diffusion kinetics and pressure tolerance for use on HPLC, UHPLC, and UPLC systems. These non-porous polymeric particles minimize analyte band spread and enhance mAb separations, giving you superior component recovery, peak shape, and component resolution. The BioResolve SCX Columns were designed alongside the BioResolve CX pH Buffer Concentrates, which work together to provide simple-to-implement charge variant profiling – so you can achieve high resolution and robust separations.

SEC Columns for mAb Aggregate, Monomer, and Fragment/Clip Analyses

BioResolve SEC mAb Columns are purposely designed for organizations involved in the research and/or development of monoclonal antibody (mAb) drugs that require accurate quantitation of mAb aggregates (HMWS), monomers, and fragments/clips (LMWS). BioResolce SEC mAb Columns provide reliable, high-quality, SEC analytical data which address internal and regulatory concerns regarding these biotherapeutics.

Stay compliant with smart column options

Ideal for compliant laboratories, smart column options are available for identifying and tracking column information. The eCord is a data recording device which is permanently attached to the column body of 2.x μm particle size (2.1 and 3.0 mm internal diameter) and ACQUITY UPLC columns and is standard for those column offerings. Rather, the eConnect column tag is a permanently attached electronic tag device for HPLC columns (≥ 2.x μm particles) used with Alliance iS and Alliance iS Bio HPLC Systems that are optional. Data from column devices (eCord device or eConnect column tag) can be accessed using the respective system’s console. These smart-column abilities provide a quick overview of column history and can be utilized as a basic troubleshooting tool. Data residing on these devices are automatically imported by and later searchable via Empower CDS.

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Related

IonHance
Improve analyte retention and peak shape with IonHance modifiers and buffers for LC and LC-MS techniques like reversed-phase protein, peptide and small molecule separations and charge variant analysis.

BioAdvisor
Simplify the process of choosing the best chemistry solutions for your application with the Waters BioAdvisor, which enables you to select an appropriate UPLC/UHPLC or HPLC column and/or chemistry consumable for a desired application, all organized by molecule type.

VanGuard Column Protection
Prolong analytical column lifetime while maintaining chromatographic performance with VanGuard Pre-columns and cartridges.

ACQUITY Arc Bio
The ACQUITY Arc Bio System keeps large molecules intact and on the move, for better sample recovery and minimal carryover, whether the chromatographic mode is reversed phase (RP), ion exchange (IEX), size exclusion (SEC), or hydrophobic interaction (HIC).

Offers and Discounts

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BioResolve Columns

Waters BioResolve Columns represent the pinnacle of innovation for tackling the complex challenges associated with mAb-based and other biotherapeutic drug analyses. Engineered to perform seamlessly across UPLC, UHPLC, and HPLC platforms, these columns provide application-specific standards and deliver superior, out-of-the-box performance tailored for precise biological separations.

The specialized chemistry of BioResolve consumables is crucial for achieving batch and column consistency during mAb separations. These columns offer reversed-phase solutions designed for both intact and IdeS digested mAbs. They feature a robust cation-exchange-based system for detailed mAb charge variant analyses and a high pore volume, 200 Å SEC setup for comprehensive analysis of mAb aggregates, monomers, and fragments. This versatility ensures flexible, reproducible, and high-resolution separations, enhancing data reliability.

BioResolve Columns are enhanced with BioResolve Guards, which significantly increase the operational lifetime of the columns without compromising performance. The innovative Cation-Exchange column technology effectively minimizes band spread, improving the separation and quantification of mAbs. Additionally, Waters guarantees the performance of each column, system, and separation method with standards like the NIST-based Intact mAb standard, mAb Size Variant standard, and mAb Charge Variant standard.

The system is complemented by BioResolve CX pH buffer concentrates and IonHance CX-MS buffers, which simplify the implementation of charge variant profiling for on-line IEX-MS analysis. These solutions offer optimized pH gradients and are specifically formulated to deliver cleaner spectra and reduce non-desired noise, supercharging, and ion suppression in LC-MS analyses.

The BioResolve Column lineup includes several key technologies and characteristics tailored to meet the rigorous demands of biotherapeutic analysis:

  • VanGuard FIT, an all-in-one guard and column design, simplifies installation and significantly extends column lifetime.

  • BioResolve RP mAb Polyphenyl Columns enhance peak capacity and provide minimal injection-to-injection carryover, allowing operation at lower temperatures to prevent on-column sample degradation.

  • BioResolve SCX mAb Columns feature non-porous, 3 μm particle technology that ensures optimal protein diffusion kinetics and pressure tolerance, offering reliable separation and accurate charge variant quantitation across a wide range of mAbs.

  • BioResolve SEC mAb Columns are designed for precise quantitation of monoclonal antibodies, high molecular weight aggregates, and lower molecular weight fragments, with ensured consistency and reproducibility across different columns.

    • For laboratories focused on compliance, Waters provides smart column options such as the eCord and eConnect column tags. These devices are permanently attached to the column body, allowing for easy identification and tracking of column information. This smart-column technology provides a quick overview of column history, facilitating troubleshooting and ensuring data integrity through automatic importation and searchability via Empower CDS.

    Waters BioResolve Columns are meticulously crafted to address the specific analytical challenges of modern laboratories engaged in the development and quality control of biotherapeutics. By improving the speed, sensitivity, and resolution of methods development and ensuring compliance and reliability in routine use, these columns stand as essential tools for advancing the field of mAb and biotherapeutic drug analysis.

    FAQs About Waters BioResolve columns

    1. What is the BioResolve column?
    The BioResolve column is a high-performance liquid chromatography (HPLC) column designed for the separation of biomolecules such as proteins, peptides, and oligonucleotides.

    2. What are the benefits of using BioResolve columns?
    BioResolve columns offer high resolution, reproducibility, and sensitivity for the separation of biomolecules. They are also compatible with a wide range of mobile phases and can be used for a variety of applications.

    3. What types of biomolecules can be separated using BioResolve columns?
    BioResolve columns can be used for the separation of a wide range of biomolecules, including proteins, peptides, oligonucleotides, and other biomolecules.

    4. What is the recommended protocol for using BioResolve columns?
    The recommended protocol for using BioResolve columns includes equilibrating the column with the appropriate mobile phase, loading the sample onto the column, and eluting the biomolecules of interest using a gradient of mobile phase.

    5. What is the shelf life of BioResolve columns?
    The shelf life of BioResolve columns is typically 2 years from the date of manufacture, provided they are stored in the recommended conditions. It is recommended to store the columns at room temperature and protect them from direct sunlight.