Role of public quality standards for biological medicines.

摘要

The growing interest in the characterization and control of biologic medicines, now including biosimilar and interchangeable biologic medicines, supports development of public specifications that help ensure the quality of drug substances and drug products. For synthetic or semisynthetic (small) chemicals, a manufacturer's best analytical method is one that is rapid and specific with respect to the starting materials and processes employed to produce it. These control procedures typically arise from characterization studies and experimental analytical procedures that are not yet optimized. Similarly, the approach a manufacturer takes to characterize a biologic leads to methods, procedures and acceptance criteria that focus on monitoring and controlling the quality of the biological drug product. As with chemical drug products, tests for biological medicines are often optimized specifically to the processes, starting materials and ancillary materials used in production. In both cases, the more closely linked the procedures are to the processes and materials involved in the drug product's manufacture, the more the procedures become increasingly specific to a single product.