Predictive stability in biopharmaceuticals and vaccines: Perspectives and recommendations towards accelerating...

The perspective review discusses predictive stability computational modeling and scientific risk-based approaches to prospectively assess long-term stability and shelf-life of biotherapeutics and vaccines. New regulatory approaches are considered in the context of evolving industry guidelines which are expected to lead to increased usage in clinical trials and market applications. Case studies for many critical quality attributes are broadly covered. Model methodologies, complexities, and mitigations, as well as emerging technologies, are also explained. Outputs of an industry-wide survey elucidate how biopharmaceutical companies are navigating this changing environment. Altogether, it is suggested that predictive stability holds promise for accelerating patient access to new medicines by overcoming stability-related bottlenecks while further enhancing scientific understanding and product robustness.