The pharmaceutical industry is under increasing pressure to transform its manufacturing practices. Traditional processes, often reliant on vast quantities of energy, water, and hazardous chemicals that can pollute our ecosystems, face growing scrutiny from regulators, the public, and investors. Embracing green chemistry is no longer just an ethical imperative; it’s becoming a crucial strategy for pharmaceutical manufacturers to ensure long-term sustainability, drive innovation, and maintain a competitive edge. This shift requires consideration of the environmental impact of the entire product lifecycle, from production to use and disposal, and to adopt greener manufacturing processes throughout the industry.
A 2022 study published in the Environmental Toxicology and Chemistry journal measured 61 different drugs in river water from 1,052 locations across 104 countries. They found that 43% of sites had drug levels exceeding safe ecological thresholds. In some locations, up to 34 APIs were identified in the water.[i] With certain APIs now named as priority substances in European water regulations, companies must adopt green chemistry strategies fast or risk falling foul of regulators and causing further harm to the environment.
Implementing a green chemistry strategy
The term green chemistry was first coined in the 1990s, gaining more traction over the past decade as ESG targets have become more ambitious. It aims to reduce the use or production of hazardous substances and find reliable, sustainable alternatives. When applied successfully, these principles can significantly enhance efficiency and result in improved manufacturing processes. Getting ahead of market pressure and increasingly stringent environmental regulations surrounding product safety are further advantages; GlobalData’s ESG Sentiment Polls Q1 2025 found that 50% of the 399 respondents believe most companies still only value ESG as a marketing exercise. Pharmaceutical manufacturers that demonstrate a genuine commitment to sustainability can build brand loyalty with customers and clients who place value in ESG when choosing suppliers.
To develop a successful green chemistry strategy, manufacturing companies need to examine every stage of the production process to identify areas for change. Even at a molecular level, effective waste reduction can be achieved through atom economy to create efficient chemical reactions by maximizing the incorporation of reactant atoms into the desired product, thereby reducing waste. By using enzymatic catalysts instead of stoichiometric reagents, the pharma industry can further reduce waste and increase selectivity.
However, the transition to sustainable practices isn’t without its challenges. Designing sustainable processes that offer the same performance as traditional materials can be costly and time-consuming, and it also presents regulatory hurdles. Yet, the long-term benefits of green chemistry far outweigh these obstacles. Companies are increasingly investing in research and development to overcome these challenges and drive innovation in sustainable manufacturing.
The hazardous reality of peptide therapeutics
The traditional manufacturing of peptide therapeutics relies heavily on solvents like Dimethylformamide (DMF) and N-Methyl-2-pyrrolidone (NMP), which present significant hazards. Both DMF and NMP are classified as substances of very high concern by the European Chemicals Agency, with safety considerations including reproductive toxicity and irritation of the eyes, skin, and respiratory system; DMF can also cause liver damage. Furthermore, regulations such as REACH (the European Union’s regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals) impose restrictions on these solvents to protect human health and the environment. For example, NMP is restricted under Annex XVII of REACH, and DMF restrictions were implemented from 12 December 2023. To ensure a more sustainable future for peptide production, it is essential to move away from DMF and NMP.
The power of biocatalysis
Among the promising green chemistry methods, biocatalysis stands out as a powerful and versatile tool for sustainable drug synthesis. Enzymes, as naturally occurring biological catalysts, offer numerous advantages, including lower energy consumption, reduced waste and byproducts, and safer process conditions compared to traditional petroleum-based processes.
A key advantage of biocatalysis is its flexibility. It can be seamlessly integrated into existing manufacturing processes to enhance their efficiency and sustainability, or it can be employed in the design of entirely new, streamlined synthesis routes for complex molecules. Biocatalytic reactions can be precisely tailored to suit the desired chemical transformation, and enzymes can be introduced at various stages of the production process, or even constitute the entire process. Furthermore, enzymes can be produced at industrial scales to meet specific customer needs, making biocatalysis a scalable and adaptable solution for pharmaceutical manufacturing.
While sustainability is a crucial driver for adopting biocatalysis, it’s important to emphasize that this approach also offers significant efficiency and robustness benefits. By optimizing reaction conditions, reducing the number of steps, and minimizing waste, biocatalysis can lead to more cost-effective and reliable production strategies.
The forefront of pharma sustainability
Biosynth, a partner for products and services for the life sciences and diagnostics industries, has built a strong reputation innovative chemistry and biochemistry solutions with green chemistry principles at its core.
By harnessing the power of enzymes, Biosynth offers clients a sustainable and eco-friendly alternative to traditional chemical methods. This approach enables highly specific, efficient, and selective chemical transformations, leading to higher yields, reduced waste, and the ability to generate chiral molecules. Biocatalysis can be applied to enhance the sustainability of current manufacturing processes or to design custom synthesis routes tailored to specific reaction requirements. Enzymes can be produced at scale to suit the customer’s needs and integrated at any stage of the production process.
Biosynth’s expertise in biocatalysis empowers the company to tackle complex synthesis challenges and provide customized solutions, including enzyme screening, process optimization, and scale-up production. The company also offers comprehensive technical support to ensure seamless integration of biocatalysis into client projects.
In addition to its biocatalysis capabilities, Biosynth provides comprehensive strategies to reduce, reuse, and recycle chemical waste, utilizing innovative techniques such as continuous manufacturing. Minimizing energy use is an important feature of its approach, with the company putting its expert understanding of the regulatory landscape into practice to ensure consistent and cost-effective green production of chemicals at both laboratory and commercial scales.
To further advance its commitment to sustainability, Biosynth has established a global green manufacturing council to drive knowledge sharing, innovation, and collaboration across its life sciences and diagnostic services. As part of this, they have recently pioneered a method of generating peptides without DMF/NMP that maintains the efficiency and yield of traditional synthesis, exemplifying the company’s commitment to developing sustainable solutions that are also practical and efficient for manufacturing.
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