Development of Patient-Focused Commercial SpecificationsUnderstanding of Clinical Relevance and Criticality of Quality Attributes

摘要

The CASSS chemistry, manufacturing, and controls (CMC) Strategy Forum on 23 January 2019 in Washington, DC, was entitled, "The Development of Patient-Focused Commercial Specifications Through Understanding of Clinical Relevance and Criticality of Quality Attributes." This forum covered the definition, identification, control, and management of patient-focused attributes throughout the life cycle (from discovery through approval) of biological products, including vaccines. Participants investigated how to differentiate through the product development life cycle which attributes are "clinically meaningful" from those applied for manufacturing capability and/or process consistency. Speakers explored which attributes have been identified as critical quality attributes (CQAs) and which have been shown to have no clinical relevance in addition to how those determinations were reached.