Abolghasem Beheshti1, Ali Ghalibafi2, Parvaneh Pakravan2*
- Department of Chemistry, Payame Noor University (PNU), P. O. Box 19395-3697, Tehran, Iran
- Department of Chemistry, Za.C., Islamic Azad University, Zanjan, Iran.
* Correspondence to: pakravanparvaneh@yahoo.com, parvaneh.pakravan@iau.ac.ir
Abstract
The pharmaceutical industry is undergoing a critical transition from traditional batch manufacturing toward sustainable, continuous, and Green-by-Design processes for API synthesis. This review explores advanced methodologies, including biocatalysis, multi-enzyme cascades, and continuous flow chemistry, which significantly enhance atom economy, selectivity, and environmental compatibility. While these technologies offer superior efficiency and reduced waste, their industrial implementation faces substantial hurdles. Key challenges include the complex engineering of scale-up, specifically regarding heat and mass transfer control, the economic viability of enzymatic processes, and the necessity for real-time pharmaceutical analysis to ensure product purity. By integrating advanced synthetic strategies with rigorous sustainability metrics and robust analytical workflows, the industry can bridge the gap between laboratory innovation and large-scale production. Ultimately, overcoming these technical and economic barriers is essential for developing a more efficient, resilient, and environmentally responsible drug manufacturing landscape.
Keywords
API Synthesis, Review Articles, Drug manufacturing, artificial inteligence, industrial challenges
