Charge heterogeneity analysis

Pursue the end goal with confidence. Achieve the full picture and accelerate decisions with comprehensive characterization of biopharmaceutical charge variants.

Overview

Break through barriers to quickly and confidently make decisions to push the best drug candidates forward from the start.

Charge heterogeneity analysis enables an understanding of critical attributes that could impact protein therapeutic stability. Early understanding and continued monitoring of a candidates charge profile is important to reduce risk and compress drug development timelines.

In order to make informed decisions on drug candidate developability early, there is a need for comprehensive charge variant analysis with detection of charge variants, and direct identification of what those variants are in a timeline keeping with the fast-pace of biotherapeutic development.

Forge a new path with a clearer understanding of the attributes that impact protein therapeutic stability from early stages. Confidently detect and fully identify charge variants during cell-line and early product or process development phases with optimized CE and MS based workflows that speed up timelines without compromising quality.

Charge variant identification on a single platform

Workflow

Prepare for any scenario, make informed decisions on product developability early with comprehensive charge variant analysis.

Interpreting the structural differences of charge variant components can take weeks and requires the use of multiple analytical methods and instruments, creating a bottleneck in gaining critical information.

Decrease the chance of product stability or safety issues, enable the study of more conditions during cell line development with a fully integrated icIEF-UV/MS workflow for charge heterogeneity analysis.

The Integrated icIEF-UV/MS workflow provides multiple pieces of critical data upfront without manual sample manipulation. Quickly and confidently accelerate candidate selection by achieving separation, quantitation, and identification of biopharmaceutical charge variants and their proteoforms in minutes.

  • Significant reduction in time to result from weeks to minutes
  • Confident characterization and identification of proteoforms with MS
  • Reproducible quantitation of charge variants

Charge variant identification on a single platform

Suited for:

  • Comprehensive characterization of charge variant-associated quality attributes
  • Charge variant analysis throughout development
Intabio ZT system

Eliminate the guess work and monitor biologics at the intact-protein level, gaining insights into charge variant-associated quality attributes.

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Biologics Explorer software

Be empowered with highly accurate and informative workflows for fully characterizing protein therapeutics and viral vector proteins.

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High-resolution charge profile monitoring

Workflow

Navigate analytical challenges for a wider variety of new modality drug candidates.

The characterization of charge heterogeneity and determination of isoelectric point (pI) adds a critical dimension to establishing identity, purity, post-translational modification and stability of therapeutic protein preparations. Characterization and monitoring of protein therapeutic charge variants can be challenging with the growing number and wider variety of new modality drug candidates.

Adapt to the ever-changing pipeline with a platform capillarty isoelectric focusing (cIEF) workflow designed to deliver high-resolution, and reproducible data allowing for easier scale up in routine use environments. cIEF workflows leverage a single separation method to perform cIEF analysis of multiple mAbs across a broad pH range. The workflow is greatly simplified by the use of a platform method, resulting in reduction or elimination of method optimization and easier scale up for deployment in routine environments.

  • Achieve ultra-high-resolution separation between isoforms
  • Be confident in your results with reproducible, accurate pI determination
  • Scale cIEF analysis for routine use with a simple platform method

High-resolution charge profile monitoring with cIEF

Suited for:

  • High-resolution charge variant monitoring
  • Rapid screening assays throughout cell line development
BioPhase 8800 system

Purpose-built for the biopharmaceutical scientist for efficiency and quality, enabling multiple samples to be run in parallel.

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BioPhase Capillary Isoelectric Focusing (cIEF) kit

Experimental protein isoelectric focusing point (pI) and analysis of charge variants.

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Rapid charge profile assessment

Workflow

Take back your time with fast, easy to use CZE solutions that are simple to transfer globally.

Analyze mAb charge variants for identity and stability with high resolution in a shorter amount of time.

  • High throughput charge heterogenity information
  • Save time with fast, simple sample preparation
  • Develop simple, transferrable methods

Fast and simple charge profile assessment with CZE

Suited for:

  • Comprehensive characterization of charge variant-associated quality attributes
  • Charge variant analysis throughout development
PA 800 Plus system

Characterize therapeutic molecules with confidence with the kit-based system.

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CZE Rapid Charge Variant Analysis kit

Native state charge variant analysis

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Associated applications

Intact protein analysis

Confidently select lead candidates and ensure reproducible product quality. Discover fast and reliable solutions that simplify identification and characterization of complex molecules at the intact level.

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Multi-attribute methodology

Pursue simpler, faster and more accurate product quality profiles. Reclaim time for innovation and reduce overall analytical testing burden with software solutions for product quality attribute (PQA) monitoring.

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