Current status and prospect for future advancements of long-acting antibody formulations.

Introduction: Biologics, especially monoclonal antibodies (mAbs), have become a major class of therapeutics in recent years addressing the needs of millions of patients and becoming one of the best-selling treatments in the pharmaceutical market. A wide range of multifaceted chronic diseases have benefitted from antibody therapeutics. Long-term treatment for chronic diseases with mAb therapies can mean a lifetime of frequent injections.

Characterization of a novel modification to monoclonal antibodies: thioether cross-link of heavy and light chains.

A novel, nonreducible thioether bridge between the light and heavy chains of different IgG1 monoclonal antibodies has been characterized. An additional band with an apparent molecular weight of 92 kDa was detected when monoclonal antibodies were analyzed by reducing capillary gel electrophoresis (rCGE) and reducing SDS-PAGE. To further investigate this observation, an early-eluting peak in the size exclusion chromatogram of a reduced and alkylated monoclonal antibody was collected and characterized by liquid chromatography, mass spectrometry, and gel electrophoresis.