Active Chemistry Materials & Manufacturing

Bio2Amine-Fampridine: delivering sustainable small molecule API manufacturing

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A UK startup is swapping heavy metal catalysts for biological enzymes to manufacture a key multiple sclerosis drug, cutting carbon emissions and production costs. The drug, fampridine (also known as dalfampridine), helps improve walking speed in people with MS, but its current manufacturing relies on energy-intensive metal-catalysed hydrogenation. HydRegen, a biotech start-up, has developed enzyme-based methods that work at room temperature and pressure, using water rather than organic solvents. In this project, the company partners with Drochaid, a specialist in catalyst testing, to scale up the biological process and benchmark it directly against the existing metal-based route. The goal is to produce hard data on cost, energy use, and waste reduction for a single active pharmaceutical ingredient (API). If successful, the workflow becomes a template that can be rapidly applied to other drugs and chemical intermediates. This matters because pharmaceutical manufacturing is a major source of industrial carbon emissions and hazardous waste. A proven biological alternative could shift parts of the supply chain toward greener, cheaper production without compromising drug quality or safety.

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HydRegen is an early stage life-science start up committed to delivering next-generation manufacturing technologies that bridge between chemistry and biology, to fast-track cost and carbon competitive process that meet safety and sustainability requirements for UK manufacturing. Drochaid is a well-established industry specialist in catalyst screening, testing and characterisation, delivering catalyst benchmarking across the chemicals sector (including with Pharmaceutical companies), and is an expert in catalytic hydrogenation processes that are central to this project In this project, innovation and development of green, bio-manufacturing strategies for Active Pharmaceutical Ingredients (APIs) at HydRegen are tested and scaled by industry experts, Drochaid. The resulting process is benchmarked against state-of-the-art metal-catalysed processes, to provide data for sustainability and cost improvements and reporting. Targeted at a specific API in this project, the workflows and developments will provide a 'blue print' for rapid deployment across many other APIs and intermediates by project end.

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