Regulatory agencies require comprehensive characterization of monoclonal antibodies (MAbs) to ensure purity and efficacy. This includes a thorough analysis of aggregate forms and charge variants during various product approval stages during the biopharmaceutical development process.
Due to these requirements, researchers face many challenges, such as:
- Screening cultures for IgG titer, aggregation and charge variants during development
- Purification of MAbs
- Identification and quantification of MAb aggregates
- Characterization of MAb charge variants
Here, we present a study, titled, Automated Monoclonal Antibody 2-Dimensional Workflow: from Harvest Cell Culture to Variant Analysis, (downloadable PDF) describing a workflow that completes MAb affinity purification, size-exclusion analysis, and charge variant analysis in less than one hour! In the study, a 2-Dimensional (2D) high performance liquid chromatography (HPLC) workflow is automated using an integrated HPLC system.
The two columns used to provide high-throughput MAb characterization are our size-exclusion and ion-exchange monoclonal antibody analytical columns (Thermo Scientific MAbPac SEC-1 size-exclusion column and Thermo Scientific MAbPac SCX-10 column). The MAbPac SCX-10 column is intended for high-resolution separation and analysis of monoclonal antibody variants and delivers high resolution separation with shorter run times using either salt or pH gradients. By incorporating this column into the platform, the entire workflow from harvest cell culture to MAb variant analysis can be completed in less than one hour.
Like what you are learning?
By the way, check out this sample chromatogram showing the MAbPac SCX-10 column achieving a high-resolution analysis of MAb variants in only 15 minutes! (downloadable PDF).
MAb Analysis Platforms
Also, if you are interested, you can check out our four HPLC systems specially designed for MAb analysis:
- Biocompatible Analytical LC system
- x2 Dual Liquid Chromatography Automated system
- Analytical Autosampler with Fraction Collector
- Rapid Separation Nano Liquid Chromatography system
- Proteomics Multidimensional Liquid Chromatography system
This monthly enewsletter focuses on the challenges and solutions for biopharmaceutical product discovery, development, and production. It covers recent applications, posters and papers, strategies and technologies. If you have any questions or comments or want a topic featured in the newsletter, write to the market manager at BiopharmaSolutions@thermo.com.
Let us know of your MAb challenges in the Comments box below. Our experts will be pleased to answer your questions!