LIFE-GREENAPI

Development & demonstration of low environmental impact innovation and optimization practices in pharma production

LIFE-GREENAPI is a 3-year initiative coordinated by Angelini Pharma and carried out in collaboration with the University of Leiden. The aim is to propose a technological shift in Active Pharmaceutical Ingredients (APIs) in an efficient, environmentally friendly and innovative way, promoting sustainability in the European Pharmaceutical Sector, a difficult one to decarbonize given the stringent regulatory limits.

The project aims to test, scale-up at pre-industrial level, and demonstrate a more efficient, greener, and innovative process for producing APIs, which are the responsible ingredients for the therapeutic effects of pharmaceutical products.

The project in numbers   

Why

European pharmaceutical companies need to address the environmental pollution due to pharmaceuticals throughout their entire life cycle.

This is what emerged from recent research that indicates the pharmaceutical industry to be significantly more emissions-intensive than other sectors and with greater disparity in environmental commitments and practices.

In fact, the requirements set in the European Green Deal with its ambition of zero pollution have prompted fine chemicals and pharmaceutical industries to integrate greener production practices into their production processes, leading to an optimization of resource use and emissions and a partial reshoring of APIs, raw materials, and intermediates production.

Within this context, LIFE-GREENAPI represents a core initiative of Angelini Pharma’s green transition strategy, through which Angelini Pharma inspires and encourages the broader pharmaceutical sector in Europe to fully embrace environmental sustainability in its production processes.

What 

LIFE-GREENAPI seeks to optimize the traditional batch chemistry method for API production by integrating it with an innovative flow chemistry approach, creating a continuous production process.

This technological innovation will lead to a series of positive environmental and climate impacts, such as reducing the use of chemicals, energy, and water, the waste and the Greenhouse gas (GHG) emissions, thus presenting several advantages, including:

• increased reaction rates;
• lower volumes of solvents used;
• energy and water efficiency;
• waste reduction;
• increased safety.

How

LIFE-GREENAPI is being conducted in collaboration with the Institute of Environmental Sciences at the University of Leiden, The Netherlands, that is monitoring the environmental impact of the program through a dedicated Life Cycle Assessment (LCA) and risk-analysis approach. LCA is a method of assessing the environmental impact associated with all stages in the life cycle of a given commercial product, process, or service, thus resulting as a key methodology for sustainability by design, an important theme in the EU Green Deal. Within LIFE-GREENAPI, LCA is applied to assess Angelini Pharma’s innovations in the fine chemicals production processes and the related environmental benefits, towards a continuous and iterative study of the system, from the lab to the pre-commercial phase.

The project is based on the following key actions:

1. Developing & testing the technological innovation at 3 scales: engineering, pilot, and pre-industrialization;
2. Monitoring environmental impact through a dedicated LCA and risk analysis approach, with the involvement of the University of Leiden;
3. Extending the technology to an additional API production process, and it is being implemented through 7 different Work Packages:

• WP1 Project management
• WP2 Engineering
• WP3 Pilot
• WP4 Pre-industrialisation
• WP5 Safety and Sustainability by Design & KPI monitoring
• WP6 Sustainability, replication & exploitation of project results
• WP7 Networking, Communication & Dissemination

About the LIFE Programme

The LIFE Programme is the EU's funding instrument for environment and climate action. It has been bringing green ideas to LIFE since 1992 and, to date, has co-financed over 5,500 projects. For the 2021–2027 period, the EU has increased LIFE Programme funding by almost 60%, up to €5.4 billion, and included the new clean energy transition sub-program.

LIFE-GREENAPI Development & demonstration of low environmental impact innovation and optimization practices in pharma production is co-funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or CINEA. Neither the European Union nor the granting authority can be held responsible for them.