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MERGING SUSTAINABLE AND DIGITAL CHEMICAL TECHNOLOGIES FOR THE DEVELOPMENT OF GREENER-BY-DESIGN PHARMACEUTICALS

Periodic Reporting for period 1 - SusPharma (MERGING SUSTAINABLE AND DIGITAL CHEMICAL TECHNOLOGIESFOR THE DEVELOPMENT OF GREENER-BY-DESIGN PHARMACEUTICALS)

Reporting period: 2022-09-01 to 2024-02-29

According to the European Commission, "the EU chemical strategy for sustainability aims to ensure that chemicals are produced and used in a way that maximizes their contribution to society while avoiding harm to the planet and to current and future generations". Therefore, integrating sustainability dimensions into pharmaceutical products is a priority. Key factors for sustainable development include the use of renewable sources, process intensification strategies, adherence to chemical safety principles, recyclability, and adoption of technologies with low environmental impact. Synthetic chemistry can play a pivotal role in this endeavor, particularly in drug design, facilitating cleaner and more efficient processes for constructing molecular architectures with specific functions. The pharmaceutical industry serves as a major driver for economic growth and provides health products and technologies for the benefit of all. While pharmaceutical demand is steadily increasing in the EU and emerging competitive countries like China, India, and Brazil, the industry is under growing pressure due to environmental concerns. Notably, the pharmaceutical industry is responsible for generating a significant share of pollution. The "E-factor", which measures the ratio between the mass of waste generated and the mass of product synthesized, is a key metric used to assess the environmental friendliness of chemical processes. In pharmaceutical companies, the E-factor for drug product synthesis typically ranges from about 25 to 100, which is considerably higher than that of the oil-and-gas industry. This underscores the urgent need for sustainable development within the pharmaceutical sector.

Efforts to minimize the use of hazardous chemicals, reduce greenhouse gas emissions, and promote material reuse, and recycling in a circular manner are crucial for achieving safe and sustainable pre-market pharmaceutical design. Additionally, ensuring efficient and timely supply of life-saving drugs while addressing manufacturing bottlenecks is essential. Although resistance to change is common in the pharmaceutical industry, maintaining competitiveness and fostering innovation necessitate embracing advancements for streamlined and sustainable chemical manufacture.

To meet the drug demand of European citizens and promote novel technologies for sustainable pharmaceutical production, collaborative research, and innovation involving various stakeholders are vital. SUSPHARMA aims to tackle these societal challenges in pharmaceutical synthesis, striving to reduce pollution generated during drug manufacturing. To address these challenges and facilitate a green and digital transition, as well as ensure effective supply of health technologies and products, the project will focus on research and innovation activities aimed at: (a) Designing heterogeneous catalytic methods instead of homogeneous counterparts (CAT-to-PHARMA). (b) Utilizing novel bio-based platform molecules for pharmaceutical manufacturing to ensure a greener-by-design approach to synthesis (WASTE-to-PHARMA). (c) Developing cutting-edge continuous-flow manufacturing technology that is greener, low in energy consumption and emissions, utilizing less solvent or recycling solvents, in alignment with the objectives of the European Green Deal (FLOW-to-PHARMA). (d) Integrating innovative synthetic methodologies with novel purification methods and robust digital solutions to eliminate carcinogenic impurities in pharmaceuticals and increase environmental and Good Manufacturing Practice compliance (PUR-to-PHARMA). (e) Implementing digital transformation or robotics for competitive, scalable, distributed, and on-demand methods of production (DIGITAL-to-PHARMA). (f) Implementing green all-aqueous strategies for drug encapsulation and controlled delivery (CAPSULE-to-PHARMA).