Company insight
Pioneering sustainable peptide synthesis
Bachem’s pioneering work in replacing dimethylformamide in solid-phase peptide synthesis exemplifies how sustainability and scientific excellence can go hand in hand.
I
n the evolving landscape of pharmaceutical manufacturing, sustainability is no longer a choice –
it’s a necessity. Bachem, a global leader in peptide production, is taking steps to redefine solid-phase peptide synthesis (SPPS) by replacing hazardous solvents like dimethylformamide (DMF) with greener alternatives. This initiative not only aligns with environmental goals but also sets a new benchmark for responsible innovation in the life sciences industry.
The challenge of greener chemistry SPPS enables efficient production of complex peptides by driving reactions to completion using excess reagents. High conversion rates are essential to avoid low yields and impurities. This method is widely adopted due to its scalability, automation and robust performance, requiring minimal process development. With a well-established supply chain for building blocks and solvents, SPPS has revolutionised peptide API manufacturing. At Bachem, the expert team specialises in producing life-saving complex peptides at all scales with unmatched precision and quality.
Why DMF needs a replacement DMF has long been the solvent of choice in SPPS due to its physical properties like polarity and viscosity, which are well-suited for resin swelling, reagent solubility and efficient reactions. However, its reprotoxic nature has led to increasing regulatory scrutiny. Recently, DMF was added to Annex XVII of the EU REACH regulation, signalling impending restrictions on its use within the EU. This regulatory shift, coupled with growing environmental concerns and Bachem’s commitment to sustainability, has prompted it to explore safer, more sustainable alternatives.
www.worldpharmaceuticals.net
Using state-of-the-art SPPS, Bachem demonstrates the successful scale-up of DMF-free synthesis processes.
Collaborative innovation In partnership with Novo Nordisk, Bachem conducted extensive studies to identify environmentally benign solvents suitable for large-scale SPPS. The research focused on different alternative solvents and solvent mixtures, evaluating key parameters such as solubilisation properties, resin swelling, and Fmoc removal and coupling chemistry. The breakthrough came with the discovery that specific binary solvent mixtures can mimic the polarity and viscosity profiles of DMF. These mixtures not only reduce toxicity but also offer novel ways to mitigate common side reactions in SPPS.
From lab to large-scale production Bachem’s commitment to practical application is evident in its successful scale-up of DMF-free SPPS processes. Using automated SPPS, it demonstrated the feasibility of producing therapeutic peptides on a 7.5mmol scale, with results comparable with traditional DMF-based methods. These findings were further validated in reactors with capacities up to 1,000 litres, showcasing that green chemistry can be both scalable and viable.
A vision for the future
The development of a predictive tool for assessing solvent usability streamlines process development, enabling faster and more efficient adoption of green solvents. Bachem’s roadmap includes continuous refinement of its solvent toolbox, guided by scientific rigour and a deep understanding of chemical processes. “Our goal is to enable the entire peptide community to benefit from our results,” says Dr Stefan Eissler, vice- president of peptide manufacturing at Bachem. “Innovation in this field is key for the future, and we are taking this challenge very seriously.” By embracing green chemistry, Bachem is not only reducing its environmental footprint but also empowering partners and customers to achieve their sustainability goals. As regulatory pressures mount and the demand for environmentally friendly solutions grows, Bachem’s leadership in this space positions it as an enabler of change. ●
www.bachem.com 71
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85
