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Abstract

Biopharmaceutical formulation development stands at the forefront of modern medicine, offering targeted therapies with enhanced efficacy and reduced side effects compared to conventional drugs. However, this field is fraught with unique challenges that require innovative solutions to ensure stability, bioavailability, and patient safety. Challenges include protein instability, formulation complexity, diverse administration routes, immunogenicity risks, and scalability issues. Innovations such as advanced drug delivery systems, stabilization technologies, biophysical characterization methods, continuous manufacturing, and personalized medicine approaches are revolutionizing biopharmaceutical formulation. Regulatory oversight ensures that these advancements meet stringent safety and efficacy standards. This abstract explores the evolving landscape of biopharmaceutical formulation development, emphasizing the critical role of innovation in shaping the future of precision medicine.