The regulatory quality guidances (Q8 – Q10) have set the expectation to develop pharmaceutical products based on a comprehensive quality by design approach. These expectations have permeated our industry as the new gold standard. Pharmaceutical development and commercialization programs are now well-versed in risk assessment processes used to prioritize and focus efforts in a science-based and rigorous manner to enable an intentionally designed quality product. The multivariate nature of drug products has posed a significant challenge to the industry, with respect to quality by design, that must now more aggressively leverage the knowledge of pharmaceutical scientists to rationalize product designs via science-based approach. The deployment of computational and predictive methods have progressed in recent years as the industry continues to drive development costs down by eliminating or reducing experimentation where appropriate. These efforts are augmenting the scientific understanding of drug product processes and scale-up. However, their use creates an additional challenge to establish the confidence of the prediction and how that translates to the design space. The purpose of this presentation is to discuss the future scientific gaps that must be addressed to develop a drug product using a comprehensive QbD approach, with reflections on the current state.&'
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