Biosimilars and BiobettersTrần Tín
Establish protein structure comparability with confidence
The development of and market for biosimilars and biobetters/biosuperiors is one of the fastest growing segments in the biopharmaceutical market. Biosimilars are follow-on products that have a comparable molecular profile to the innovator drug. Biobetters are follow-on biologics where the original innovator molecular profile has been modified to improve drug efficacy or safety.
According to current worldwide practice, manufacturing processes for biosimilars and biobetters need not exactly match the originator’s methods. This gives biosimilar and biobetter manufacturers the opportunity to improve their production technology and implement a more rigorous process. The focus of biosimilars and biobetters development is on extended efforts to characterize the compounds and prove their equivalence and, in the case of biobetters, variation relative to the innovator drug.
Extensive analytical and characterization studies to demonstrate comparability can be required. The accuracy of each analysis is critical. Fortunately, new innovations have resulted in sophisticated high-resolution analytical tools that can provide the analytical sensitivity and repeatability needed so that biosimilars and biobetters can be characterized with confidence. Agilent offers a comprehensive portfolio of methods and technologies for the complete and highly accurate characterization of biopharmaceuticals, including confirmation of protein sequence, identification of post translational modifications, intact protein and subunit analysis, glycan analysis, and host cell protein analysis. Agilent provides samples-to-answers solutions, including fast and automated sample preparation, LC separation, robust biocolumns, sensitive mass spectrometry data acquisition, and data analysis software. You can trust Agilent systems and services to deliver accurate and reproducible results and streamline your workflow.