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

Introduction

LIFE-GREENAPI aims at proposing a technological shift in Active Pharmaceutical Ingredients (APIs) production, enabling sustainability of the European Pharmaceutical Sector, which is recognized as being one of the most difficult sectors to decarbonize, given the stringent regulatory limits.

Collaboration and Development

Angelini Pharma, in collaboration with the University of Leiden, will engineer, test, scale-up, and demonstrate at an industrial level the environmental benefit of an innovative approach for the manufacturing of APIs, switching from batch to flow-chemistry.

Implementation Strategy

The technological innovation will be first developed and tested on a selected high-production volume API (400 t/y in Europe), and then replicated on two additional small molecules, in order to demonstrate the broad spectrum of applicability.

Expected Environmental Impacts

The novel approach is expected to lead to important environmental impacts:

1. Reduction in Use of Dangerous Chemicals:

   • 6.5 tons reduction initially, expected to become more than 473 tons/y after 5 years of replication.

2. Energy Consumption Reduction:

   • 33% reduction, corresponding to 5 MWh saved in the 3-year project and 360 MWh/y after 5 years from the project end.

3. Waste Management Improvement:

   • A reduction of more than 10 tons of inappropriately managed waste (714 tons/y after 5 years).

4. Water Usage Reduction:

   • A reduction of more than 880 m³ (64,192 m³/y after 5 years).

5. CO2eq Reduction:

   • Overall reduction is equal to 31 tCO2eq within the project duration and 2,230 tCO2eq/y after 5 years.

Market Impact

LIFE-GREENAPI is bringing to the EU market a concrete way to support pharma industries in their journey towards net-zero emissions: a very difficult goal for such a strictly regulated sector.

Stakeholder Involvement

LIFE-GREENAPI will involve several stakeholders from the Pharma business in Europe and will pave the way for the broad adoption of the flow-chemistry technology in APIs manufacturing.

Assessment and Evaluation

The project will demonstrate the real savings, both from environmental and economic points of view, through a full Life Cycle Assessment (LCA) and risk assessment that will be performed on the whole production process.