Company insight Navigating a greener future
Collaboration and harmonisation are now critical to achieving sustainable pharmaceutical manufacturing. Biosynth proves how green chemistry, innovative partnerships and regulatory alignment can accelerate the industry’s transition to a lower-impact future.
Unitaid’s 2023 report identified that up to 95% of greenhouse gases for priority medicines come from raw material acquisition and manufacturing. This highlights the urgent need to move away from traditional, resource-intensive practices, which rely heavily on energy, water and hazardous chemicals. Green chemistry is now essential for achieving sustainability, driving innovation and fostering competitiveness. However, this shift requires a change in mindset, driven by innovative partnerships and the need for global regulatory harmonisation.
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Collaborating for greener synthesis The complex nature of modern drug synthesis means that no single company can be an expert in every field. This is where strategic partnerships with specialised contract chemistry organisations become essential. Such collaborations enable pharmaceutical manufacturers to tap into cutting-edge expertise and technologies without the massive capital investment and lengthy R&D cycles required to build those capabilities in-house.
A prime example of this synergy is the application of biocatalysis. Biocatalysis, which utilises engineered enzymes as catalysts, stands out as a powerful method in green chemistry. Enzymes offer significant advantages over traditional petroleum-based processes, including better yield, greater energy efficiency, reduction of multi-step reactions, replacement of expensive metal catalysts and improved regulatory acceptance. Biosynth, with experience in greener chemistries, including biocatalysis applications and in-house enzyme development capabilities, has built a reputation on green principles, providing
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he pharmaceutical industry is approaching a tipping point in its benefits to human health worldwide.
Twelve principles of green chemistry.
clients with sustainable and highly efficient alternatives to traditional chemistries that can be significantly more cost-effective.
By leveraging partnerships, pharma companies can not only enhance the sustainability of their current operations but also design custom synthesis routes tailored to specific requirements, ensuring they remain at the forefront of innovation. This collaborative model helps accelerate the transition to sustainable practices, which can be costly and time- consuming when done alone. Biosynth’s recent pioneering of a method to produce peptides without hazardous solvents like dimethylformamide (DMF) and N-methyl-2-pyrrolidone (NMP), while maintaining efficiency, is a testament to the practical benefits of this approach and its ability to provide greener solutions that are viable for large-scale manufacturing.
Global regulatory landscape While partnerships can drive innovation, a fragmented global regulatory landscape poses a significant barrier to the widespread adoption of green chemistry. The EU, for instance, has taken a proactive stance with regulations like REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), which classifies solvents like DMF and NMP as substances of very high concern. Both are now restricted under REACH to protect human health and the environment.
The US regulatory framework, overseen
by the Environmental Protection Agency (EPA) under the Toxic Substances Control Act (TSCA) and the Food and Drug Administration (FDA) for drug manufacturing, operates on different principles. The lack of coordination forces companies to develop and implement separate, often redundant, manufacturing processes to meet different regional standards. This costly duplication of effort and resources not only stifles innovation but also delays the market entry of more sustainable drugs.
Consider a global pharmaceutical company operating in both markets: it may need to invest in separate R&D to develop different synthetic routes or establish separate supply chains to comply with the distinct regulations.
Common goals and standards Achieving greater regulatory alignment is crucial. Harmonising requirements would streamline the path for companies to adopt green alternatives, providing a clearer and more consistent framework. By working towards a common set of standards, regulators in the US and the EU can incentivise and accelerate the transition to greener, more efficient manufacturing practices on a global scale. This collective effort would benefit not only the environment but also the entire pharmaceutical ecosystem by reducing costs, improving efficiency and accelerating the delivery of essential medicines to patients. ●
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