Chemiluminescent biosensors for pharmaceutical analysis: innovations, challenges, and future prospects

Chemiluminescent (CL) biosensors have rapidly emerged as indispensable analytical tools within the multifaceted domains of pharmaceutical research, development, and clinical diagnostics. This prominence stems from their intrinsic attributes such as higher sensitivity, low background noise, and inherent amenability to miniaturization for portable, real-time readout capabilities. This comprehensive review meticulously presents and critically evaluates the most recent innovations in CL-based biosensing platforms specifically engineered for diverse pharmaceutical applications. A primary focus is directed towards the pioneering innovations in the development of CL biosensors with enhanced and tailored emission profiles, the strategic and synergistic integration with an array of sophisticated signal amplification strategies, and the ingenious adaptation of CL detection techniques into highly portable, integrated, and microfluidic devices. Key applications, encompassing stringent drug quality control and authentication, precise pharmacokinetic analysis for personalized medicine, and the critical, rapid detection of counterfeit and substandard medications, are discussed with a rigorous, critical lens, highlighting both their transformative potential and current practical limitations. Furthermore, the review critically assesses emerging prospects, including the advent of advanced wearable sensors for continuous monitoring, the transformative potential of artificial intelligence-assisted diagnostics for data interpretation and predictive modeling, and the imperative for sustainable, eco-friendly reagent design. This article thus serves as both a comprehensive technical resource, elucidating the intricate scientific underpinnings and practical advancements, and a forward-looking perspective on the pivotal and evolving role of chemiluminescent biosensing in modern pharmaceutical analysis.