Periodic Reporting for period 1 - PharmEco (Advancing Safe and Sustainable by design Practices in Pharmaceutical Manufacturing)
Okres sprawozdawczy: 2024-11-01 do 2025-09-30
PHARMECO addresses the urgent need for more sustainable pharmaceutical manufacturing in Europe, where the healthcare sector accounts for an estimated 3 to 8% of global CO2 emissions. It leverages the Safe and Sustainable by Design (SSbD) framework, a proactive approach promoted by EU initiatives that -while not yet legally mandated- is emerging as best practice and a source of competitive advantage. PHARMECO bridges the gap between high-level SSbD principles and the practical challenges of more sustainable chemical synthesis, biomanufacturing, and decontamination.
PHARMECO’s overarching objective is to accelerate the adoption of SSbD-compliant processes across pharmaceutical manufacturing. To achieve this, PHARMECO aims to embed SSbD principles into early-stage process design, ensuring that manufacturing safety, environmental impact, economic feasibility, quality impact and scalability guide decisions from the very beginning. Technological innovations under development include solvent-free and aqueous chemical synthesis, intensified and continuous processing platforms, advanced biomanufacturing systems with real-time monitoring and control, and low-emission decontamination technologies. These solutions are selected for their potential to reduce solvent use, energy consumption, greenhouse gas emissions, hazardous substances, and overall environmental impact. Complementing these efforts, PHARMECO is establishing harmonized Life Cycle Assessment (LCA) methodologies, environmental metrics, and sustainability indicators to enable evidence-based decision-making, regulatory alignment, and comparability across the pharmaceutical supply chain. A modular, publicly accessible digital decision-support tool will integrate sustainability evaluation, process simulation, and scenario analysis, guiding chemists and engineers toward safe, high-quality, and environmentally responsible manufacturing choices.
A core element of PHARMECO’s strategy is translating more sustainable laboratory-scale innovations into industrially relevant demonstrations. The project will scale up intensified, aqueous, and solvent-free chemical processes; continuous, digitally controlled biomanufacturing operations; and low-emission cleaning and decontamination processes. These demonstrations aim to validate technical feasibility, robustness, and scalability while quantifying environmental benefits such as reduced greenhouse gas emissions, lower energy demand, and improved material efficiency. This ensures that SSbD-driven process intensification moves beyond concept to real-world industrial application.
PHARMECO’s pathway to impact combines technological development, methodological harmonization, and proactive stakeholder engagement. Standardized sustainability assessments will support regulatory compliance, enable cross-industry comparability, and will provide a foundation for integration into future European environmental guidelines. Collaboration with regulatory authorities, the European Commission, industrial consortia, and academic partners will ensure alignment with evolving policies, emerging needs and technological developments, while also facilitating acceptance of new manufacturing approaches, and strengthening knowledge exchange. Through open-access webinars, publications, and educational initiatives, PHARMECO equips current and future scientists with the skills to implement SSbD principles and sustainable manufacturing strategies.
PHARMECO is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement nr. 101165889. The JU receives support from the European Union's Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bio, MedTech Europe, and Vaccines Europe.
PHARMECO’s overarching objective is to accelerate the adoption of SSbD-compliant processes across pharmaceutical manufacturing. To achieve this, PHARMECO aims to embed SSbD principles into early-stage process design, ensuring that manufacturing safety, environmental impact, economic feasibility, quality impact and scalability guide decisions from the very beginning. Technological innovations under development include solvent-free and aqueous chemical synthesis, intensified and continuous processing platforms, advanced biomanufacturing systems with real-time monitoring and control, and low-emission decontamination technologies. These solutions are selected for their potential to reduce solvent use, energy consumption, greenhouse gas emissions, hazardous substances, and overall environmental impact. Complementing these efforts, PHARMECO is establishing harmonized Life Cycle Assessment (LCA) methodologies, environmental metrics, and sustainability indicators to enable evidence-based decision-making, regulatory alignment, and comparability across the pharmaceutical supply chain. A modular, publicly accessible digital decision-support tool will integrate sustainability evaluation, process simulation, and scenario analysis, guiding chemists and engineers toward safe, high-quality, and environmentally responsible manufacturing choices.
A core element of PHARMECO’s strategy is translating more sustainable laboratory-scale innovations into industrially relevant demonstrations. The project will scale up intensified, aqueous, and solvent-free chemical processes; continuous, digitally controlled biomanufacturing operations; and low-emission cleaning and decontamination processes. These demonstrations aim to validate technical feasibility, robustness, and scalability while quantifying environmental benefits such as reduced greenhouse gas emissions, lower energy demand, and improved material efficiency. This ensures that SSbD-driven process intensification moves beyond concept to real-world industrial application.
PHARMECO’s pathway to impact combines technological development, methodological harmonization, and proactive stakeholder engagement. Standardized sustainability assessments will support regulatory compliance, enable cross-industry comparability, and will provide a foundation for integration into future European environmental guidelines. Collaboration with regulatory authorities, the European Commission, industrial consortia, and academic partners will ensure alignment with evolving policies, emerging needs and technological developments, while also facilitating acceptance of new manufacturing approaches, and strengthening knowledge exchange. Through open-access webinars, publications, and educational initiatives, PHARMECO equips current and future scientists with the skills to implement SSbD principles and sustainable manufacturing strategies.
PHARMECO is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement nr. 101165889. The JU receives support from the European Union's Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bio, MedTech Europe, and Vaccines Europe.
A key focus has been on translating high-level SSbD concepts into practical guidance for pharmaceutical development. Current route design practices for both small- and large-molecule manufacturing were reviewed, identifying gaps and establishing a baseline for SSbD-aligned best practices. This work enables early-stage manufacturing decision-making that integrates safety, environmental, economic, legally viable, quality impact and scalability considerations.
Significant technical progress has been achieved across all technological innovation streams in PHARMECO. In chemical synthesis, research priorities include solvent-free mechanochemical and aqueous reactions, non-precious metal catalysis, and electrochemical and photochemical activation, biocatalysis as well as sustainable peptide and oligonucleotide synthesis. Laboratory work has advanced from model selection to detailed parameter optimization, supported by specialized analytical workflows and new equipment. Biomanufacturing has advanced through breakthroughs in plant-based upstream production processes, as well as the design and early operation of a continuous manufacturing platform that integrates process analytical technologies, digital control systems, and sustainability metrics. Upgrades to bioreactor platforms, development of soft sensors, and flow-through chromatography systems will drive intensified, digitally enabled bioprocessing. In decontamination, a lab-scale supercritical CO2 cleaning system has been constructed and is undergoing validation as a low-emission alternative to sterilization by toxic ethylene oxide gas. Preparatory work has also advanced on cleaning-in-place (CIP) and sterilization-in-place (SIP) optimization and wastewater remediation.
The project has initiated the development of a digital sustainability decision-support toolbox, defining its scope, data requirements, and modular architecture to guide process design. Early data collection from chemical synthesis, biomanufacturing, and decontamination studies provides a foundation for Life Cycle Assessment-based evaluations, enabling predictive models and sustainability metrics to be integrated into process development.
Through these activities, PHARMECO has built a solid scientific and technical foundation for advancing more sustainable pharmaceutical manufacturing. The project integrates SSbD principles across multiple stages of production, targeting scalable solutions for industrial adoption and a clear route toward measurable reductions in environmental impact, resource consumption, and greenhouse gas emissions.
Significant technical progress has been achieved across all technological innovation streams in PHARMECO. In chemical synthesis, research priorities include solvent-free mechanochemical and aqueous reactions, non-precious metal catalysis, and electrochemical and photochemical activation, biocatalysis as well as sustainable peptide and oligonucleotide synthesis. Laboratory work has advanced from model selection to detailed parameter optimization, supported by specialized analytical workflows and new equipment. Biomanufacturing has advanced through breakthroughs in plant-based upstream production processes, as well as the design and early operation of a continuous manufacturing platform that integrates process analytical technologies, digital control systems, and sustainability metrics. Upgrades to bioreactor platforms, development of soft sensors, and flow-through chromatography systems will drive intensified, digitally enabled bioprocessing. In decontamination, a lab-scale supercritical CO2 cleaning system has been constructed and is undergoing validation as a low-emission alternative to sterilization by toxic ethylene oxide gas. Preparatory work has also advanced on cleaning-in-place (CIP) and sterilization-in-place (SIP) optimization and wastewater remediation.
The project has initiated the development of a digital sustainability decision-support toolbox, defining its scope, data requirements, and modular architecture to guide process design. Early data collection from chemical synthesis, biomanufacturing, and decontamination studies provides a foundation for Life Cycle Assessment-based evaluations, enabling predictive models and sustainability metrics to be integrated into process development.
Through these activities, PHARMECO has built a solid scientific and technical foundation for advancing more sustainable pharmaceutical manufacturing. The project integrates SSbD principles across multiple stages of production, targeting scalable solutions for industrial adoption and a clear route toward measurable reductions in environmental impact, resource consumption, and greenhouse gas emissions.
Not applicable yet, given the early stage of the project.