Formulation and Quality – Biomolecular
2019 PharmSci 360
The setting of specification acceptance criteria typically incorporates knowledge of the critical quality attributes, an understanding of the pivotal clinical experience, and a statistical consideration of the clinical batches produced. With accelerated timelines and streamlined development, few clinical lots (e.g., 2-3) may be produced, which are insufficient to provide useful statistics or meaningful manufacturing experience, and furthermore, show little lot-to-lot variation due to robust clinical manufacturing. As a consequence, the justifications of appropriate acceptance criteria are focused on science- and risk-based assessments of patient impact. This presentation will provide the strategy and examples to show that attribute focused, clinically relevant specifications provide a balance between having appropriate control over high risk attributes to ensure product quality for the patient, and flexibility for low risk attributes, as appropriate, for a robust supply chain.