Advances in recombinant protein bioprocessing: integrating technological innovation and environmental sustainability.

This study aims to provide an integrated assessment of recombinant protein bioprocessing by combining technological maturity frameworks (TRL/BRL) with environmental sustainability indicators. A structured literature-based analysis was conducted, covering recent advances in bioprocess engineering, including precision fermentation, artificial intelligence-assisted control, and sustainability assessment tools such as life cycle analysis (LCA) and process mass intensity (PMI). Recombinant protein production using microbial systems, such as Escherichia coli, demonstrates high scalability and cost-efficiency, with reported emissions significantly lower than those of conventional pharmaceutical synthesis (≈ 20 vs 351 kg CO2 eq/kg product). However, critical gaps persist between laboratory-scale innovation and industrial implementation, particularly in emerging economies. The integration of digital tools, including AI and digital twins, shows strong potential to improve process optimization and scale-up success rates. Bridging the gap between technological development and industrial deployment requires integrating process design, sustainability metrics, and readiness frameworks. Targeted innovation strategies are essential to accelerate biopharmaceutical development and enhance global health outcomes.