Roadmap for Commercial Nanomedicine Development: Integrating Quality by Design Principles with Pharmaceutical Nanotechnology.

Integrating Quality by Design (QbD) principles into nanomedicine development marks a paradigm shift from traditional empirical approaches to more systematic risk-based strategies. This review explores the application of QbD in pharmaceutical nanotechnology, focusing on nanoliposomes as a drug and gene delivery model. We examine various QbD models, including factorial, Plackett-Burman, Box-Behnken, and Taguchi experimental designs, alongside response optimization methods such as artificial neural networks (ANNs), mathematical optimization, and overlay plots. A comparison of QbD versus conventional optimization techniques highlights the potential of QbD to improve process efficiency, reduce variability, and enhance product quality. Case studies demonstrate the practical application of QbD in developing nanoliposomal formulations for treating complex diseases such as diabetes, cardiovascular diseases, rheumatoid arthritis, and CNS disorders. Furthermore, we discuss the regulatory and industrial considerations for commercializing nanoliposomal-based therapies, emphasizing FDA guidelines and the challenges associated with scaling up nanomedicine production. Different from available reviews in the field, this review uniquely integrates diverse QbD models with nanoliposome development, offering practical insights. Also, we aimed to bridge laboratory research with industrial scale-up and regulatory requirements. Overall, the present review critically contrasts QbD with conventional methods, using real case studies to highlight its superiority in ensuring product quality, consistency, and efficiency.