112: Greener pathways in pharmaceutical development: streamlined sustainability assessment for early phase and continuous improvement

Abstract: Pharmaceutical development and manufacturing increasingly incorporate sustainability targets, yet challenges remain regarding the effectiveness and consistency in assessing greenness. Guiding agencies and industry consortia provide recommendations and frameworks for green chemistry metrics; however, these tools span multiple platforms without fit-for-use consolidation. To increase efficiency and reduce barriers to routine application, a streamlined approach for incorporating green principles into pharma development and manufacturing has been developed and applied. This work presents a practical assessment tool that consolidates recommended and customized green chemistry metrics into a single, user-friendly platform. The methodology is demonstrated through case studies for active pharmaceutical ingredient (API) processes with molecular weights ranging from less than 200 to over 1000 g/mol. The results emphasize incorporating green principles in early-phase development while also demonstrating their use in continuous improvement programs for commercial APIs. Measured improvements include reduced waste generation, decreased energy consumption, elimination of hazardous materials, and increased process and method efficiency. These examples highlight the value of the integrated approach in supporting synthetic route selection, identifying key environmental and safety impacts, and guiding process improvements.