Review of approaches and examples for monitoring biotransformation in protein and peptide therapeutics by MS.

摘要: Biotherapeutic drugs have emerged in quantity pharmaceutical pipelines, and increasingly diverse biomolecules are progressed through preclinical clinical development. As purification, separation, mass spectrometer detection data processing capabilities improve, there is opportunity to monitor drug concentration by traditional ligand-binding assay or MS measurement metabolism, catabolism other biomolecular variants present circulation. This review highlights approaches examples of monitoring biotransformation biotherapeutics as these techniques poised add value development years come. The increased use such approaches, the successful quantitation biotherapeutic structural modifications, will provide insightful for benefit both researchers patients.