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Transforming into a sustainable European pharmaceutical sector

Periodic Reporting for period 1 - TransPharm (Transforming into a sustainable European pharmaceutical sector)

Periodo di rendicontazione: 2022-06-01 al 2023-11-30

Pharmaceuticals comprise a wide variety of chemical compounds designed to guarantee safe and effective therapies. The active pharmaceutical ingredients (APIs) are those that deliver the beneficial health effects experienced by the patients. The goal of the project is to develop more sustainable and greener APIs that simultaneously reduce the environmental footprint and the dependence on third countries for API production. The EU-funded TransPharm project delivers digital tools and and will deliver guidelines, also based on artificial intelligence, for the development of greener pharmaceutical products and APIs, as well as models to judge their impact. The result should be a more independent and competitive European pharmaceutical industry, which can ensure the timely delivery of sustainable and green therapeutics to its citizens.
Starting from literature data bases, artificial intelligence methods are used to extract relevant data to predict important features of molecules which are of major importance for API’s. Several characteristics of the molecules are being predicted such as solubility, but also the biodegradability of compounds. This feature is crucial to develop greener pharmaceuticals that degrade more readily and more completely in the environment leading to a better surface water quality. Further, much effort is being focused on developing more sustainable methods to prepare API’s. Not only is being looked at methods to reduce the formation of hazardous residues, also attention is paid to develop continuous flow methods and telescoped methods to reduce the carbon footprint of the synthesis methods and to reduce the use of transition metals.
However the footprint of the pharmaceutical sector is not only created by the production, also other aspects have to be accounted for which are less obvious, such as the impact of limited biodegradability, health benefits, local legal constraints,... Therefore, a holistic Life Cycle Assessment is being developed to evaluate the sustainability of pharmaceuticals. This assessment will take also into account the ecotoxicological profile which will be based on high throughput research that will be performed during the project.
The project will be performed in close collaboration with all stakeholders of the complete process in order to judge the drive and the economic viability to transition towards greening the pharmaceutical production.
The TransPharm project aims at developing greener pharmaceutical production schemes which can lead to bringing back the production to Europe and to contribute to the logistic difficulties of the sector.

The pharmaceutical sector is coping with a number of important challenges at the moment. These challenges range from logistic problems to provide the required APIs to patients, over environmental issues related to residues in surface water and hazardous residues, leading to high development costs directing the API production to low-income countries.
The objective of the TransPharm project is to contribute to most of the above challenges by greening the pharmaceutical production and optimizing production methods in order to reduce the carbon footprint of the pharmaceutical sector and to try to bring back some of the API production to Europe by stimulating more regional production. This should lead to a more secure supply and to a better situation for patients in Europe.
The research project started 18 months ago, and a lot of groups had quite severe problems to recruit the required personnel due to the war on talent many universities and companies are struggling with. It illustrates the economic possibilities for highly educated Master students in the European area and the need to educate more young people in this area of research.
The different work packages have been initiated and progress well and already promising results have been obtained. A library of ciprofloxacin analogues has been designed and some derivatives have been synthesized for a better biodegradability and the synthesis of more of these Cip-hemi analogues is progressing.
Further, very nice results have been obtained in the development of a recuperation method for Cyrene, the most important renewable solvent that can be used as a replacement for dimethylformamide. Extraction performed at elevated temperature, in batch and in flow, lead to high recuperation of the solvent. This procedure is now further studied in flow by counter current extraction using a commercial Zaiput system.
Protocols to scan and interrogate literature data on flow processes are in development and progress well. Promising results on artificial intelligence data are available and more specific results will be available in due course.
Further, important work has been done to get a complete overview of the life cycle of API’s and the impacts on environment, economics and social life. Next to that, stakeholders have been interrogated and an overview of the interviews have been collated.
More recent work is related to the development of training methods and educational material.
Because of the early phase of the project, no results beyond the state of the art have been obtained yet. The Cyrene recuperation method is good on the way for that; however the method still needs some further optimization in flow testing several mixing systems and different type of continuous flow reactors. Further some very interesting results are obtained on the development of renewable building blocks (see above).