Green API manufacturing
INTRODUCTION
As generic competition increases it is crucial to examine different ways to improve efficiency and cost reduction in the manufacturing process for the active pharmaceutical ingredient (API). The Pharma companies have therefore organized themselves in recent years by forming multidisciplinary teams of chemists, analysts and chemical engineers to develop a synthesis process that could improve precisely these aspects. To achieve this objective it was crucial to develop new processes that obviously took into account the production capacities of the plant itself but which in fact inexorably led to the development of a green process path.
INVESTING IN SUSTAINABILITY
Our industry needs a radical change in its approach to sustainability and limiting emissions if we are to fulfill our shared social responsibility to minimize our impact on the climate.
When talking about the circular economy and the improvement of the quality of life it’s now essential to invest in the development and practices of innovation and optimization with low environmental impact in pharmaceutical production with the aim of re-engineering APIs that lead to compliance with the environment and even economic savings.
The requirements set out in the European Green Deal with its zero pollution ambition must push us to integrate the principles of green chemistry and green engineering into our fine chemicals production processes leading to an optimization of the use of resources and emissions.
FLOW CHEMISTRY: A RIGHT CHOICE?
European pharmaceutical companies need to address the environmental pollution from API production throughout their entire life cycle. This is what clearly emerges from several key EU documents, including the Strategic approach to pharmaceutical production and its impact on the environment and the Pharmaceutical strategy for Europe.
Today more than ever a certain and stronger contribution from the pharmaceutical sector is needed for sustainable development, considering the influences that our industry has on the environment and on issues that are very sensitive: water, waste and climate.
A concrete example that goes in this direction – but others could be cited – is flow chemistry technology which is at the heart of the topic in order to reduce waste, increase energy and water efficiency and maximize safety and economic advantages.
ANY ADVANTAGES?
The general objective is to develop and demonstrate a more efficient, greener and innovative fine chemicals production process.
Till now APIs are mainly produced by the application of standard batch chemistry so the switch to an innovative and novel technology will be more and more needed with a strong potential in flow chemistry approach.
Why Flow Chemistry?
Based on the results of previous activities conducted at lab level, the application of flow chemistry presents a series of potential advantages:
- increased reaction rate: in closed and narrow reactors, higher temperatures and pressures can be reached with the same amount of reagents increasing the transformation rate;
- improved use of solvents: from a preliminary analysis, a signifi cant reduction of solvent is expected;
- energy efficiency: given the reduction of hours needed to carry out the reaction in-fl ow instead of in batch mode, it is possible to reach the same amount of product with an efficient use of energy;
- waste reduction: the increased level of effi ciency of the process allows a substantial improvement of waste reduction over batch processing;
- water efficiency: the innovative process is expected to lead to an improved water effi ciency, considering both the process and the artesian water;
- increased safety: reactions in a closed cycle generate low emissions, if compared to a batch reactor, normally open.
CARLO LUSSO
CDMO BD & project portfolio management of Angelini Fine Chemicals about Europe & Asia
Angelini Pharma S.p.A. | Fine Chemicals Business Unit, Italy