10181895Establishing measurement standards for recombinant alternatives to synthetic peptide productionActiveGrant for R&DInnovate UKThe world is experiencing a sharp rise in the use of therapeutic peptides---particularly the new GLP-1 medicines for obesity and diabetes. Demand is increasing so rapidly that global production is projected to reach metric-tonne levels in the coming years. Currently, almost all these medicines are produced through a chemical process called solid-phase peptide synthesis (SPPS), which generates enormous amounts of waste: producing just 1 kg of peptide can result in over 13,000 kg of chemical waste. As demand grows, this method is becoming environmentally unsustainable and more challenging to scale. Constructive Bio is developing an innovative method to produce these medicines, using specially recoded microorganisms to generate peptides through fermentation rather than chemical synthesis. This biological approach could be cleaner, more scalable, and more resilient for the NHS and global supply chains. However, because peptides contain non-natural building blocks and have traditionally been produced chemically, there is no existing regulatory pathway to demonstrate that a biologically produced version is equivalent to a chemically manufactured one. For pharmaceutical companies and regulators to adopt greener manufacturing, they need clear evidence that both versions of the medicine meet the same standards for quality and safety, and an understanding of any differences arising from the two production methods. In this project, Constructive Bio will collaborate with the National Physical Laboratory (NPL), the UK's national measurement authority, to compare a peptide produced chemically with the same peptide produced biologically. NPL will employ advanced analytical techniques to evaluate identity, purity, structure, and impurities from each manufacturing process, delivering a thorough, science-based comparison. This work will establish the groundwork for future regulatory assessments and help create a clear pathway for approving peptides produced through sustainable biological processes. It will also instil industry confidence to adopt greener technologies at scale. By enabling regulatory acceptance of low-impact biomanufacturing, this project supports the UK's leadership in engineering biology, strengthens our national sustainability goals, and helps create a more resilient and environmentally responsible medicine production system for the future.