PHARMECO November 25 Webinar series - Webinar 5 - Introduction of the SSbD-framework and adaptation to Pharma

Introduction to the SSbD Framework & Adaptation to Pharmaceuticals Caroline Moermond (RIVM) Nina Melander (RISE) Hannah Welsh (TU Berlin) 2 Outline Introduction to PHARMECO Speaker: Hannah Welsh – TUB, Germany Introduction to the JRC SSbD Framework Speaker: Nina Melander – RISE, Sweden From SSbD to SSbC for Pharmaceuticals Speaker: Caroline Moermond – RIVM, Netherlands Key take-aways Speaker: Hannah Welsh – TUB, Germany Q&A Moderator: Hannah Welsh –TUB, Germany Introduction to PHARMECO Hannah Welsh (TUB) 01 Funded by the European Union and the private members of the IHI JU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them. Corporate slidedeck 4 Executive summary Public private partnership advancing Safe and Sustainable by design Practices in Pharmaceutical Manufacturing Project Goal: Advancing sustainable practices in pharmaceutical manufacturing of small molecules, biologics and tides, as well as decontamination Implementation of process optimizations and technological innovations at various stages of pharmaceutical manufacturing Standardized sustainability assessment methods Consortium: 31 international partners, •Including major pharmaceutical and medtech companies, research institutions, government bodies, and SMEs •14 different countries Coordinator: Ghent University (BE) / Project leader: Sanofi (DE) Budget: 45M €, co-funded by the European Union and the private members of the IHI JU Duration: 01/11/2024 – 31/10/2030 Expected outcome Enhanced sustainable manufacturing with SSbD methods, reducing resource use and emissions, offering a public eco-design toolbox, and standardized sustainability assessment methodology in healthcare •Process intensification •↓Energy and ↓water consumption •Innovative fermentation and purification technologies •Innovative PAT •Plant-based biologics production •Renewable resource of single-use materials •Process design •Pilot manufacturing •Scale up WP6 Pilot manufacturing, Upscaling Corporate slidedeck 5 PHARMECO implementation: overall work plan structure Overall structure of the work plan WP8 Standardization and harmonization of sustainability assessment systems •Process intensification, simplification •Unit operations in flow and batch •Innovative PAT •Green raw materials options •New technologies (photo-, electro-, mechano-, water-based chemistry, biocatalysis) •Sustainable peptide and oligonucleotide synthesis •Retrospective API synthesis design •Small and large molecules •“SELECT” criteria: Safety, Environment, legal, COGs, quality, throughput •Integrated databases and decision tool WP1 Coordination, Management and Governance WP7 Sustainability assessment and steering WP9 Dissemination, exploitation, communication and networking activities •Greener cleaning, desinfection and sterilization processes •Sterilization technology based on supercritical CO2 •Reuse of process water and solvents •Wastewater remediation •Reduced energy and chemical consumption •Mitigation of antimicrobial resistance Sustainable technology platforms WP2 Route Design WP3 Chemical synthesis platforms WP5 Decontamination WP4 Biomanufacturing •Process intensification •↓Energy and ↓water consumption •Innovative fermentation and purification technologies •Innovative PAT •Plant-based biologics production •Renewable resource of single-use materials •Process design •Pilot manufacturing •Scale up WP6 Pilot manufacturing, Upscaling 6 PHARMECO implementation: overall work plan structure Overall structure of the work plan WP8 Standardization and harmonization of sustainability assessment systems •Process intensification, simplification •Unit operations in flow and batch •Innovative PAT •Green raw materials options •New technologies (photo-, electro-, mechano-, water-based chemistry, biocatalysis) •Sustainable peptide and oligonucleotide synthesis •Retrospective API synthesis design •Small and large molecules •“SELECT” criteria: Safety, Environment, legal, COGs, quality, throughput •Integrated databases and decision tool WP1 Coordination, Management and Governance WP7 Sustainability assessment and steering WP9 Dissemination, exploitation, communication and networking activities •Greener cleaning, disinfection and sterilization processes •Sterilization technology based on supercritical CO2 •Reuse of process water and solvents •Wastewater remediation •Reduced energy and chemical consumption •Mitigation of antimicrobial resistance Sustainable technology platforms WP2 Route Design WP3 Chemical synthesis platforms WP5 Decontamination WP4 Biomanufacturing Introduction to SSbD Nina Melander (RISE) 02 Funded by the European Union and the private members of the IHI JU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them. 8 8 Agenda Development of the framework The 2022 JRC SSbD-framework The 2025 JRC SSbD-framework 9 9 One voluntary approach for innovators to address the planetary triple crisis Climate change Biodiversity loss Pollution https://unfccc.int/news/what-is-the-triple-planetary-crisis Revised framework in context of the Competitiveness Compass 16 •Revised framework – draft for consultation (2025) in the context of the Competitiveness Compass •Final version will be published at the end of 2025/beginning of 2026 •“By integrating safety and sustainability from the earliest stages of innovation, the SSbD framework can support a more resilient, competitive, and innovation-based, future-proof industrial ecosystems." New addition in the revised framework (2025/2026) The new backbone of the framework 17 https://ec.europa.eu/eusurvey/files/3ad5e6d9-a13f-4183-b173-83d03ec73bee/bf0972c9-a279-4fee-9b63-4a4cb1ae2c4d New additions in the revised framework (2025/2026) 18 https://ec.europa.eu/eusurvey/files/3ad5e6d9-a13f-4183-b173-83d03ec73bee/bf0972c9-a279-4fee-9b63-4a4cb1ae2c4d New additions in the revised framework (2025/2026) 19 Clarification of the iterative nature of SSbD implementation in the innovation process and consideration of uncertainty Clarification of the complexity of assessment depending on TRL, and the use of proxies and benchmarks https://ec.europa.eu/eusurvey/files/3ad5e6d9-a13f-4183-b173-83d03ec73bee/bf0972c9-a279-4fee-9b63-4a4cb1ae2c4d 20 Same design principles Green Chemistry principles, Green engineering principles, Sustainable chemistry criteria, Circular chemistry principles 20 Material efficiency e.g E-factor Minimuse the use of hazardous chemicals/materials e.g. hazard classifications Design for energy efficiency e.g. boiling temperature Use renewable sources e.g. feedstock or energy Prevent and avoid hazardous emissions e.g. wastewater Reduce exposure to hazardous substances e.g. biodegradability Design for end-of-life e.g. durability, reparability Consider the whole life cycle e.g. recyclablility https://ec.europa.eu/eusurvey/files/3ad5e6d9-a13f-4183-b173-83d03ec73bee/bf0972c9-a279-4fee-9b63-4a4cb1ae2c4d 21 New addition in the revised framework (2025/2026) 21 Safety and sustainable assessment •The Steps 1, 2 and, 3 of the 2022 framework are now merged in one safety assessment. The use of physico-chemical properties in early assessments is now clarified. •The environmental sustainability assessment addresses the entire life cycle of the chemical/material •The socio-economic sustainability assessment is expanded compared with the 2022 framework, and it addresses the social fairness and competitiveness dimensions of the chemical/material supply chain. Integrates Critical Raw Materials more clearly. https://ec.europa.eu/eusurvey/files/3ad5e6d9-a13f-4183-b173-83d03ec73bee/bf0972c9-a279-4fee-9b63-4a4cb1ae2c4d 22 23 Safety assessment for environment, OHS, and end-user 23 https://ec.europa.eu/eusurvey/files/3ad5e6d9-a13f-4183-b173-83d03ec73bee/bf0972c9-a279-4fee-9b63-4a4cb1ae2c4d Environmental sustainability assessment 24 https://ec.europa.eu/eusurvey/files/3ad5e6d9-a13f-4183-b173-83d03ec73bee/bf0972c9-a279-4fee-9b63-4a4cb1ae2c4d Environmental sustainability evaluation system 25 https://ec.europa.eu/eusurvey/files/3ad5e6d9-a13f-4183-b173-83d03ec73bee/bf0972c9-a279-4fee-9b63-4a4cb1ae2c4d From SSbD to SSbC for pharmaceuticals Caroline Moermond (Centre for Safety of Substances and Products; VSP) "It's not easy being green..." One question… … led to: "What do we understand to be greener/more environmentally friendly regarding APIs and their use?" The GREENER concept Goal of the GREENER concept •open the dialogue between the environmental sector and drug discovery and development experts •explore the feasibility of applying these criteria in drug discovery and development 36 Drug properties and environmental characteristics interact Vidaurre et al., 2024. Drug Discovery Today 29(7): 104022 This project has received funding from the European Union’s Horizon Europe research and innovation program under grant agreement N° 101057816. WP4: Integrated Sustainability Assessment - Led by Radboud University (Ad Ragas) - Holistic Framework (Univ Gent) - Lifecycle inventory - New LCA tools - Assessment framework to assess and compare sustainability of pharmaceuticals - Trade-Offs WP5 - Preparing for the transition to greener pharmaceuticals - Led by RIVM (Caroline Moermond) - Is there a Business case for greener pharmaceutical products? - Interviews, focus groups, systematic literature review - Report Q1 2026 Trade-offs ›Safety and sustainability do not always go hand in hand! ›Trade-offs between safety and sustainability play a pivotal role in the whole lifecycle of pharmaceuticals ›Not all trade-offs are obvious or known: there are many hidden or indirect trade-offs Puhlmann et al., 2024. Step 3: Human health and environmental aspects in the final application phase ›Final use of the product Type of input data Data on effects and exposure during use and after excretion SSbD endpoint – already in R&D Patient safety (environmental risk assessment is currently performed late in development stages) SSbD endpoint – new to R&D Human health through the environment (AMR, food consumption) Relevant R&D phase Defining dose (to define exposure) Puhlmann et al., 2024. Step 4: Environmental sustainability assessment ›Impacts related to chemical/material along its entire lifecycle. ›Toxicity, climate change, pollution, resources Type of input data Data on materials, energy consumption, waste, emissions, etc SSbD endpoint – already in R&D Not covered SSbD endpoint – new to R&D From simplified to full LCA, following increasing availability of data along the process Relevant R&D phase Simplified LCA as early as possible; full LCA only possible later as required data is collected after R&D ›Standardized Assessment needed to compare medicinal treatment ›We propose a Safe and Sustainable by Comparison (SSbC) framework, that builds upon the SSbD framework –Data needed for SSbD step 1-4 is often not available in the design phase –This data is (partly) available for SSbC! –Strong link with Alternatives Assessment framework Puhlmann et al., 2024. Application of SSbD framework to pharmaceuticals ›Lack of data ›No harmonized methods ›Some parts of the environmental footprint are dynamic, how do you deal with that ›Very complex: care is complex and components are global 51 Assessment frameworks (SSbC for pharmaceuticals) Assessment frameworks (SSbC for pharmaceuticals) What can we do? ›Looking for criteria that –Are on the wish list of stakeholders –That distinguish between products and that actually matter –Should in principle be known by (and available from) industry 52 53 Snape and Moermond, in prep Questions? For more information: [email protected] We need a scientifically sound Environmental Sustainability Assessment (ESA) system for pharmaceuticals, with consensus from all stakeholders, which is tiered, robust, harmonised, and adaptable to different contexts. Conclusion international workshop April 2025 Wrap-up Funded by the European Union and the private members of the IHI JU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them. Key take-aways 56 The generic, flexible, iterative SSbD approach requires sector-specific adaptation Cross-disciplinary toolbox for early innovation/low TRL needs to be developed Education of multi-disciplinary/multi-stakeholder teams for joint, improved decision-making We need a holistic view to assess safety and sustainability in parallel. LCA helps, but is not the single solution. The current SSbD system is aimed at alternatives assessment for products with available data; a system truly for the design-phase, based on low-data availability, still needs to be developed. Q&A Funded by the European Union and the private members of the IHI JU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them.