LC-MS characterization of monoclonal antibodiesAs mentioned in an earlier post (Speeding up Monoclonal Antibody Manufacturing) the development of monoclonal antibody (MAb) therapeutics continues to be one of the largest, most important, and rapidly growing area in biomedical research. According to a report, Trends in Therapeutic Monoclonal Antibody Discovery Technology (Dr. David Meininger, Department of Protein Sciences, Merck & Co., Inc., Palo Alto, CA), “With 2012 mAb (and mAb-derivative) market sales estimated to total roughly $50 billion and the compound annual growth rate for this market estimated to exceed 8% through 2016…”.

One of the challenges of MAb characterization is that due to the heterogeneity of MAb products, a thorough characterization is necessary for their reproducible as well as safe production. Mass spectrometry is becoming increasingly important in providing valuable information on various protein properties, such as intact mass, amino acid sequence, post-translational modification including glycosylation form distribution, minor impurities due to sample processing and handling and high order structure, etc.

Here is a poster (presented at WCBP 2012) describing an LC-MS-based workflow solution that provides robust, accurate and comprehensive intact MAb characterization.

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The poster titled, A Complete Workflow Solution for Intact Monoclonal Antibody Characterization Using a New High-Performance Benchtop Quadrupole-Orbitrap LC-MS/MS, (downloadable PDF), shows that a mass error of less than 10 ppm was routinely achieved for intact mAb mass measurement. Using an on-line high resolution top-down MS-MS approach, over 40% of the fragmentation site was achieved for intact light chain that covers 100% sequence. The fast liquid chromatography, the superior resolution and mass accuracy provided by the Q Exactive OrbitrapTM MS, and accurate data analysis of this workflow provides high-confident screening tool to accelerate biopharmaceutical product development cycles.

Watch this space for the next blog on a poster describing an automated MAb 2-dimensional workflow. Also, don’t forget to comment below if you find this poster helpful in your work. We look forward to your comments!