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The pressure to reduce environmental impact is reshaping how pharmaceutical companies approach manufacturing. Sustainability is no longer a secondary consideration. It is becoming a core design requirement, shaping how processes are developed, scaled, and evaluated across the industry. At the heart of this transition is green chemistry, which is evolving from an aspirational goal into a practical, business-critical tool.

Several forces are driving this shift. Fluctuating raw material costs, tightening solvent regulations, increasing scrutiny on waste generation, and the push for Scope 3 emissions reduction have converged. At the same time, the tools and frameworks available to support sustainable process redesign have matured significantly. What was once complex or experimental is now increasingly reliable, reproducible, and scalable in industrial settings.

We recently saw these changes come together in a project with a global pharmaceutical partner. The company approached us to scale GMP manufacturing for an oncology compound initially developed by their discovery team. The requirement was to produce approximately 250 kilograms of active pharmaceutical ingredient (API) for use in clinical studies. While the original chemistry was technically sound, the proposed process proved inefficient and resource intensive. It required over ten volumes of solvent and roughly three kilograms of starting material to produce one kilogram of product. Yields were low, the impurity profile was unpredictable, and waste levels were commercially unsustainable.

Rather than simply adjusting the margins of an inefficient system, we proposed a complete redesign using green chemistry principles. The goal was to develop a route that would maintain product quality and compliance while improving yield, reducing material usage, and minimizing environmental impact.

Our approach relied on the SELECT framework, which evaluates process design through six lenses: Safety, Environment, Legal, Economics, Control, and Throughput. We combined this with internal tools such as our Process Excellence tracker and solvent usage database, allowing us to assess trade-offs across multiple parameters and propose a path forward that balanced all critical constraints.

The results were substantial. In the first synthetic step, we replaced a tertiary amine with an alternative base that significantly improved product formation. Solvent volumes dropped from ten to three. Raw material usage was reduced to nearly a one-to-one ratio with the final product. Yield after isolation nearly doubled. Across the remaining steps, solvent and reagent use were further optimized. The new route maintained full compliance and scalability, with a cleaner impurity profile and greater process control.

From initial assessment to full-scale execution, the new process was developed in just eight weeks. We began with a small proof-of-concept batch and then successfully scaled to GMP production, delivering 250 kilograms of API on schedule. The client ultimately saw a 30 percent reduction in overall manufacturing costs while meeting their regulatory and quality goals.

This case reflects a broader industry trend. Companies are beginning to recognize that process sustainability, if built in from the start, can improve performance across multiple fronts. Green chemistry is no longer something to consider after a route is established. It is increasingly being embedded at the earliest stages of development, where it can have the greatest impact.

The business case is becoming clearer as well. More efficient reactions reduce dependency on volatile raw materials. Reduced solvent usage simplifies downstream processing and waste disposal. Streamlined routes often lead to more consistent batch performance, fewer quality issues, and faster time to scale. These are not marginal gains. In many cases, they translate directly into lower risk, faster timelines, and improved profitability.

Despite this, some barriers remain. Many organizations still approach sustainability as a compliance issue rather than a strategic driver. Process teams are often tasked with optimizing yield and cost first, with environmental performance addressed later if at all. Our experience suggests that this sequence is outdated. When sustainability is treated as an integrated design challenge rather than a constraint, the overall process becomes more efficient and more resilient.

Standardized tools are playing a key role in enabling this mindset shift. Frameworks like SELECT and process mass intensity (PMI), combined with access to historical process data, are helping teams make evidence-based decisions early in development. They also provide a common language for collaboration across departments, which is essential for projects that touch chemistry, engineering, safety, and regulatory affairs.
Regulators and investors are also beginning to ask harder questions about how sustainability is embedded into manufacturing strategy. There is growing demand for transparency around waste generation, emissions, and the use of hazardous reagents. Companies that can show sustainability is integral to their development process will be better positioned to respond to these expectations and navigate future changes in policy and market dynamics.

The pharmaceutical industry is in a period of transition. Sustainability is moving from the periphery of process design to the center. This will require companies to rethink how they prioritize goals, allocate resources, and define success. The ones that thrive will be those who treat environmental performance not as a separate target, but as an essential part of scientific and technical excellence.

At Syngene, we believe this is the future of manufacturing. Our work with this client demonstrates what is possible when green chemistry is applied rigorously, supported by data, and implemented collaboratively. Cost reduction, improved yield, and a lighter environmental footprint are not trade-offs. They are outcomes of smarter, more holistic process design.