Polymeric nanofibers: Quality by design: Perspectives and prospects

Polymeric nanofibers, for biomedical and pharmaceutical use, compel process that requires precise control of multiple factors. A quality by design approach provides a risk-based framework to guide development, ensuring consistent fiber diameter, uniformity, strength and surface properties. Polymeric nanofibers -ultrafine fibers with diameters range 1–1000 nm process remarkable physicochemical characteristics, including high surface area to volume ratio, tunable porosity and mechanical flexibility, making them ideal for enhanced drug delivery, tissue engineering and wound healing applications. Integrating Quality by design (QbD) principles, guideline by ICH Q8 to Q11, systematically defined quality target product profile (QTPP), identify critical quality attributes (CQA), such as fibers diameter(100–500 nm) and drug release profiles and employs risk assessment tools like Ishikawa and failure mode effects analysis (FMEA) to optimized critical material attributes and process parameters. Predominant electrospinning fabrication, alongside scalable techniques like centrifugal and solution blow spinning, enables incorporation of natural/synthetic polymers and active compounds for control release, thereby improving bioavailability and patient compliance while reducing variability. Despite challenges in scale up and regulatory compliance, future prospects leverage multi-axial electrospinning, AI-driven modelling and composites to develop tailored, intelligent systems for cancer therapy, regeneration and beyond promising revolutionary pharmaceutical outcomes.