Charge heterogeneity analysis

Early understanding of attributes that impact protein therapeutic stability is important to reduce risk and compress drug development timelines. One such critical attribute that requires monitoring during cell-line and process development for a given biologic drug candidate is its charge profile.

Proteins have an inherent charge under any given set of conditions, and this can be altered by changes to the protein’s primary structure, or by the addition of post-translational modifications (PTMs). In order to make decisions early in product development there is a need for confident detection of charge variants, but also to fully identify what those variants are in a timeline keeping with the fast-pace of biotherapeutic development.

Overcome process challenges 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/process development phases with optimized workflows that speed up timelines without compromising quality.

Make informed decisions on product developability early with confident, charge variant analysis and identification.

The process of identifying individual charge variant components is time and labor intensive. Interpreting their structural differences can take weeks and requires the use of multiple analytical methods and instruments, increasing the complexity of the charge heterogenity analysis assay, and creating a bottleneck in gaining critical information for processes and team members downstream in the development pipeline.

Decrease the chance of product stability or safety issues, drive process development projects to completion or enable the study of more conditions during cell line development with an integrated icIEF-UV/MS workflow.

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

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

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.

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