The scope of this topic is as follows:

• To transfer approaches from green chemistry and technology into biomanufacturing by developing new types of upstream and downstream processing methods with increased efficiency, more balanced energy consumption and less waste (stainless steel vs. single-use equipment), continuous manufacturing (perfusion cell cultures vs. fed-batch), and the production of enzymes as process reagents in the manufacture of pharmaceutical products.
• To apply innovative technology to the chemical synthesis of e.g. small molecules, oligonucleotides, peptides and vaccines, by removal of hazardous chemicals, and streamline manufacturing processes and energy consumption, mainly by introducing new production and analytical technologies using “greener” solvents, smaller solvent volumes (e.g. mechanochemistry, alternatives to chromatography), continuous manufacturing processes (e.g. flow-chemistry) and emphasising catalysis and enzymatic chemistry. More sustainable sterilisation processes as alternative to ethylene oxide sterilisation for devices.
• To identify, characterise and test novel replacement materials for single-use equipment and process aids (tubing, bags, PVCs (polyvinyl chlorides)) based on materials from renewable sources, e.g. BioPET (biorenewable polyethylene therephthalate).
• To create new life cycle assessments (LCA) of drug substances and drug products of all (including new) modalities1 to gain a holistic view of the end-to-end environmental impact of all materials, energies, chemicals and wastes involved in the production of medicines, with the ultimate goal of achieving comparability of diverse manufacturing processes, technologies and products, e.g. chemical entities (tablets / liquid formulations) or biologics (lyophilised / liquid formulations).
• To promote diversified value/supply chains resulting in a shift away from dependencies on specific suppliers and ingredients, thereby promoting the security and resilience of the European pharmaceutical and healthcare industry and the health of European citizens.
• To harmonise and standardise the definitions, manufacturing ontologies, methodologies and frameworks for environmental impact assessment (e.g. LCA standards) of healthcare, including pharmaceutical products, across the European healthcare sector, and align with industries outside the EU (north America, Asia, UK etc.).
• To evaluate the applicability and relevance of the proposed solutions, existing impact assessments (e. g. life cycle assessments, based on existing industry standards, e.g. the standard developed by the Sustainable Markets Initiative, SMI) should be performed to show superiority in comparison to existing approaches.

In this project, the standardisation of environmental impact assessment methodologies (e.g. LCA) of industrial processes is prioritised rather than the individual assessment of new technologies.

The aim of this project is to avoid the accumulation or distribution of any substances of concern in nature and therefore identify new transformations that can replace stoichiometric or catalytic use of toxic reagents or catalysts, respectively.

The Chemicals Strategy for Sustainability has as its objective the transition towards safer and more sustainable chemicals in line with the SSbD principles. It will require that industry minimises, substitutes as far as possible, and phases out the most harmful chemicals in healthcare products whilst at the same time ensuring the sustainability / availability, safety, quality and efficacy of these products. 

Many programmes launched on green chemistry and green pharmaceuticals aim to demonstrate the technical feasibility of applying new methods to improve the overall efficiency and robustness of single manufacturing steps and how to assess their impact on the environment.