In 2004, the US Food and Drug Administration (FDA) introduced an innovative drug development concept, Quality by Design (QbD), which centers on a scientifically rigorous and systematic approach to ensure that every aspect of a drug product, from development to production, meets expected quality standards. This initiative ensures that every phase of a drug’s life cycle, from concept to manufacturing, adheres to stringent quality benchmarks. By emphasizing a proactive, risk-based strategy, QbD has elevated the standards of drug development, enhancing both patient safety and product efficacy. This paradigm shift has not only improved the predictability and reliability of drug outcomes but also streamlined the regulatory process, fostering a more innovative and efficient pharmaceutical industry. This review delves into the application status, potential, challenges, and future development of QbD in biological medicine. Identifying key elements and their interconnections lies in center of QbD implementation. The process development is founded on a comprehensive understanding of the relationship between critical quality attributes (CQAs) and critical process parameters (CPPs), utilizing real-time monitoring data to enhance product quality stability and minimize losses caused by nonconformity. Additionally, during large-scale production, the design space empowers enterprises to establish an operational range that ensures product quality based on thorough research. This approach creates a mutually beneficial outcome for both regulatory authorities and pharmaceutical companies. QbD, as a new drug development concept, has a broad application prospect in the biomedical field. As science and technology advance and the pharmaceutical sector evolves, the significance of QbD in future drug development is poised to escalate.