Stability and Characterization of Protein- and Nucleotide-Based Therapeutics

Throughout the development process of protein or nucleotide-based therapeutics, a broad array of analytical techniques is applied on a routine basis to measure various molecular attributes. These measurements are carried out in the context of the quality control system of the product, i.e., routine monitoring of the product quality, e.g., on stability during long-term storage or as various characterization studies aimed at broadening the knowledge of the molecule. All stages of product development rely on analytical support: cell line and purification development, formulation development, compatibility studies, comparability exercises, and also assessment of stability during production, storage, and shipping. The successful design of product control and characterization strategies to support biotherapeutic development requires intimate knowledge of the molecule in question and analytical chemistry: the potential modifications that may occur in the molecule and the analytical techniques capable of measuring these modifications.