Post-Translational Modifications in Protein Therapeutics: Importance and Analytical Tools.

Post-translational modifications (PTMs) play a pivotal role in the activity and stability of proteins and can, therefore, significantly affect the quality of protein- or cell-based biological therapeutic products. Accordingly, PTMs are often evaluated as critical quality attributes, which require thorough characterization and evaluation throughout product development. Continued progress in understanding and characterizing protein PTMs is important to enable the distribution of safe and effective biologic medicines. Currently, a wide range of analytical techniques are employed for the detection and characterization of PTMs in the biopharmaceutical context. This chapter provides an overview of PTMs relevant to therapeutic proteins and commonly used or emerging analytical tools to analyze them.