posted on 2025-04-07, 23:33authored byMarco Ferrara, Federico Della Negra, Massimo Verzini
The synthesis of
active pharmaceutical ingredients (APIs) demands
extensive resources, with solvents playing a pivotal role in shaping
the safety, health, waste, and environmental impacts of chemical processes.
To address the absence of a tailored metric for the requirements of
the pharmaceutical industry to rapidly quantify and compare these
impacts, we developed a novel tool providing concrete operational
guidance to enhance sustainability, cost-effectiveness, and operational
efficiency. This metric leverages a comprehensive data set, prioritizes
critical impact categories, and evaluates solvent quantities relative
to the product output. These features enable it to effectively identify
areas of improvement in chemical processes and guide sustainable development
initiatives. The experience of the application of the metric by a
contract development and manufacturing organization to its processes
is presented, demonstrating the effectiveness of the metric for internal
benchmarking and establishing sustainability criteria. Furthermore,
the metric provided structured, actionable guidelines to support daily
process development activities, ultimately serving as a practical
tool to achieve corporate environmental, social, and governance (ESG)
objectives. While the described benchmarking is not proposed as a
general industry standard, the method is adaptable to the unique context
and requirements of any chemical or pharmaceutical company. Case studies
underscore its capability to pinpoint high-impact solvents, support
targeted interventions, and achieve notable reductions in sustainability
impacts. Aligned with the United Nations Sustainable Development Goal
for responsible production, this metric integrates seamlessly into
process evaluation tools, enabling consistent, data-driven improvements.
Designed to complement existing methodologies rather than replace
them, it enhances chemical process assessments with a rapid, decision-focused
approach tailored to the priorities and key impact categories of the
pharmaceutical industry. This practical tool fosters sustainability
and operational efficiency, addressing critical industry needs.