A controlled vocabulary and taxonomy for the submission of quality attributes for therapeutic proteins

Abstract

Abstract Structured product quality data offer tremendous promise to revolutionize the submission of drug applications. However, the quality attributes for biological products do not have a systematic naming taxonomy, and consequently this limit poses a critical challenge in the development of systems for structured regulatory submissions. Here, we describe the creation of a controlled vocabulary with a structured taxonomical naming approach for quality attributes of therapeutic proteins. Additionally, we endeavor to make the case for why such systematic harmonized naming is required to support the successful implementation of structured data systems. We also describe the key principles of our structured naming approach, including a top-down view of the product and protein structure and a distinction between a quality attribute and the test to evaluate the attribute. Finally, we describe how this approach can accommodate emerging product types, advanced manufacturing technologies, and be used across the variety of submission sections in a regulatory dossier that discusses quality attributes.

Keywords

• Drug application
• Biopharmaceutical characterization
• Biosimilar
• Biotherapeutic
• Protein structure
• Quality attribute