Monoclonal Antibody Analysis: Applications of iCE Technology

Charge Variant Analysis of Monoclonal Antibodies with iCE

The wide-ranging emergence of monoclonal antibodies (mAbs) as first-line therapeutics has driven the demand for high-resolution analytical methods to both characterize their heterogenous makeup and to keep up with stringent regulatory guidelines. Imaged capillary isoelectric focusing (icIEF) technology is the industry standard for separation of proteins or peptides based on their isoelectric points. For decades, iCE™ systems have been used for icIEF profiling throughout the mAb manufacturing process—from scale-up to formulation development and stability testing to quality assurance (QA) of lot-to-lot consistency.

Publication Spotlight:

Determination of isoelectric points and relative charge variants of 23 therapeutic monoclonal antibodies

In this first-of-its-kind publication in the Journal of Chromatography B, researchers in Switzerland and France team up to study the ionic properties of a wide range of FDA and EMA approved reference mAbs. Using Maurice, they determined isoelectric points for 23 such antibodies and found that the experimentally obtained values agreed with those calculated by either Vector NTI or MassLynx software.

Read the full paper on pubmed: Determination of isoelectric points and relative charge variants of 23 therapeutic monoclonal antibodies

Publication Spotlight:

Physicochemical and Biological Characterization of the Proposed Biosimilar Tocilizumab

Tocilizumab (Actemra®) is FDA approved for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis, with some recently demonstrated activity against non-small-cell lung cancer.
HS628, its proposed biosimilar, has been developed by Hisun Pharmaceutical in China. In this report, ProteinSimple’s iCE technology is used to demonstrate the similarity of key critical quality attributes of HS628 to its originator product.

Read the full paper on Pubmed: Physicochemical and Biological Characterization of the Proposed Biosimilar Tocilizumab

Publication Spotlight:

Quantitation of CRM197 using icIEF with Fluorescence Detection and Capillary Western

Diphtheria toxin mutant CRM197 protein concentration can be easily measured for fermentation and purification samples using icIEF and UV absorbance techniques. But for crude cell lysates, the task is unattainable using icIEF and UV detection alone. See how researchers use Maurice’s fluorescence detection capabilities or combine with Simple Western to generate quantitative data using crude cell lysates.

Read the full paper on Pubmed: Quantitation of CRM197 using icIEF with Fluorescence Detection and Capillary Western

Want to learn more about Maurice?

Watch the video and see how Maurice can process up to 6 samples in 1 hour. The short video shows the step by step process, from sample loading to signal detection.

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