Advancing Safe and Sustainable by design Practices in Pharmaceutical Manufacturing (PharmEco)

Framework: Horizon Europe — Global Challenges and European Industrial Competitiveness
Programme: Health
Theme: Public-private partnerships
Destination: Innovative Health Initiative
Action type: Research and Innovation actions
Partnership: IHI (JU-JTI)
Countries involved: Belgium,Austria,Netherlands,France,Sweden,United Kingdom,Germany,Denmark,United States,Switzerland,Italy,Ireland,Spain,India
Call: Sustainable circular development and manufacturing of healthcare products and their quantitative environmental impact assessment (HORIZON-JU-IHI-2023-04-two-stage, 2023)
Start date: 2024-11-01
End date: 2030-10-31
Duration (months): 72.0
Total project cost (EUR): 34367098.5
EU funding (EUR): 16035533.0
Participants: 54
Project status: SIGNED

PHARMECO is supported by the Innovative Health Initiative Joint Undertaking (IHI JU). The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bío, MedTech Europe, and Vaccines Europe. The project's overall objective is to revolutionize pharmaceutical manufacturing towards sustainability by integrating environmentally friendly technologies/processes and harmonized sustainability assessments methods into healthcare industry practices. This encompasses early design phase, operation, and eventual use and disposal. The project's first objective is to enhance the early-stage development of pharmaceutical products by implementing Sustainable-by-Design (SSbD)-driven process-intensified platforms (e.g. continuous manufacturing). This involves designing sustainable processes based on so-called SELECT (Safety, Environment, Legal, Economy, Control and Throughput) criteria and setting up eco-friendly systems for producing small molecules, peptides, oligo-nucleotides, proteins and ribonucleic acid (RNA) with advanced control measures. Next, PHARMECO aims to scale up and demonstrate environmentally-friendly processes for industrial manufacturing and decontamination, which includes creating infrastructure for studying key unit operations with sustainable technology and for SSbD-driven process intensified manufacture at a scale sufficient for clinical testing and a manufacturing process that is easily transferred to a Good Manufacturing Practice (GMP) environment. PHARMECO also aims to steer the development of (bio)manufacturing processes towards sustainable production through digital decision-making tools. This involves creating a modular digital tool for assessing sustainability from multiple perspectives, evaluating practices. Finally, the project seeks to establish a standardized approach for assessing the environmental sustainability of pharmaceuticals, which involves collaboration with various stakeholders to create scientifically robust guidelines, applying consistent Life Cycle Assessment (LCA) methodologies, and facilitate regulatory adoption of standardized LCA practices. By integrating sustainability considerations into every phase of manufacturing, PHARMECO will positively revolutionize pharmaceutical industry.

Keywords: route design,decontamination,pilot and scale up,cradle to grave,lca,harmonized standards,pharmaceutical manufacturing,continuous manufacturing,process intensification,digital twin,pat,ssbd,sustainability,biomanufacturing,chemical synthesis,drug substance,green chemistry,new biological entity,new chemical entity,sterilization,supercritical co2,api,active pharmaceutical ingredient