Biopharmaceutical analysis — current analytical challenges, limitations, and perspectives

Abstract Biopharmaceutical analysis is essential for ensuring the quality, safety, and efficacy of these medicines. Nonetheless, it faces significant challenges due to the complexity of these molecules and the strict regulatory standards. This work explores the strengths, limitations, opportunities, and threats in biopharmaceutical analysis, focusing on the challenges and emerging analytical technologies and their impact on biopharmaceutical development and quality control. Key challenges identified include the complexity and heterogeneity of biopharmaceuticals leading to the requirement for a broad spectrum of analytical methods, the high cost of the required analytical instrumentation, and the need for skilled professionals to implement advanced analytical techniques. Integrating artificial intelligence-driven data analysis, automation, and multi-omics approaches can significantly improve analytical precision and efficiency. However, regulatory barriers and financial constraints remain critical obstacles to widespread adoption. This work highlights the need for industry-wide collaboration to standardize methodologies and regulations, improve data integrity, and facilitate regulatory acceptance by reviewing the last 5 years of biopharmaceutical-related works. Ultimately, the continued development of biopharmaceutical analysis, driven by technological advancements and strategic investments, is crucial for biopharmaceutical development, enhancing manufacturing efficiency, and ensuring broader access to high-quality biopharmaceuticals. Graphical Abstract