Analysis Of Biologics For Similarity Assessment Using CZE-MS Quick Assessment Of Biologics And Biosimilars By CZE-MS

Monoclonal antibodies (mAbs) are an important class of biologics for the treatment of critical diseases. Assessment of the heterogeneity of mAbs is essential for product quality control, especially for biosimliars. A biosimilar is a recombinant protein that is therapeutically similar to the reference biologic or “innovator” molecule but is manufactured with a different bioprocess. It is important to investigate structural similarities and differences between the proposed biosimilar and the innovator molecule. In fact, a critical step in the approval process of biosimilars is to assess their functional and structural similarities with the innovator. Before in-depth characterization, a quick study of a mAb for fast assessment can help save time and reduce bottlenecks with mass spectrometer usage for busy analytical laboratories.

A microfluidic CZE device, ZipChip® enables seamless integration of CZE with a variety of commercial mass spectrometers (For example, instruments from ThermoFisher Scientific, Sciex, and Bruker). For this work, a Thermo ScientificTM Orbitrap ExplorisTM 240 hybrid quadrupole Orbitrap mass spectrometer (Exploris 240 brochure) was used in conjunction with the ZipChip as shown on the right.