Characterization and establishment of specifications for biopharmaceuticals

This paper describes the role of product characterization and product specifications in the context of an overall control strategy. Due to advances in analytical characterization and biotechnology manufacturing methods, product characterization can now be used as an effective means of assessing the impact of manufacturing process changes on product quality, safety and efficacy, hence obviating the need for repeating clinical testing each time a manufacturing process change is made. The ICH specifications guidance document can serve a key role in harmonising test requirements and regulatory practices with regard to produce characterization. Consumers, regulatory agencies, and biopharmaceutical manufacturers all stand to benefit from this harmonization process.