Protein Aggregates

The analysis of the aggregation phenomenon of therapeutic proteins is of crucial importance as more and more pharmaceutical products are proteins or peptides.  Aggregation can not only result in reduced efficacy of biopharmaceuticals but also increases the risk of inducing an immune response to the mAb rather than the pathogenic antigen it was supposed to detect.  CovalX offers a unique technique for the direct characterization of therapeutic protein samples based on High-Mass MALDI mass spectrometry.  This technique is often utilized orthogonally to SEC, SEC-MALS or AUC when a discrete measurement of the aggregates is desired.  The mass measurement provides a direct detection of the species present, not an average as many techniques.

Therapeutic Antibody Aggregates

High-Mass MALDI TOF analysis (CovalX HM1) of an aggregated sample of the therapeutic protein Hab41 before (black) and after (red) cross-linking. The sample has been submitted to the SEC before cross-linking protocol with K200 MALDI MS Stabilization Kit.

The fraction analyzed exhibit a dimer (350 kDa). The high-mass analysis allows distinguishing between covalent and noncovalent aggregation.

High Mass MALDI ToF analysis of an aggregated sample of therapeutic protein Hab42 before (black) and after (red) cross-linking. The sample has been submitted to SEC before cross-linking protocol using K200 MALDI MS stabilization kit. The fraction analyzed exhibits a dimer (303 kDa) and hexamer (910 kDa).

For more details concerning protein aggregates analysis, contact us using the form on this page.

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