HydRegen Awarded Innovate UK Funding for Sustainable Pharmaceutical Production
We are pleased to announce that HydRegen, in collaboration with Drochaid Research, has been awarded significant grant funding from Innovate UK to advance its pioneering Bio2Amine biocatalyst platform. This funding supports a groundbreaking project aimed at transforming the manufacturing of Active Pharmaceutical Ingredients (APIs) through sustainable biomanufacturing solutions.
“For HydRegen, this is a real opportunity to bring together regulatory, sustainability, industrial scale up and commercialization experts to focus on the best route to market for an important API, forming a blue-print for follow on processes.” - Holly Reeve, CEO, HydRegen
Bridging Chemistry and Bio-Manufacturing
HydRegen’s Bio2Amine platform offers a novel and disruptive approach to nitro-to-amine conversion, a crucial process in pharmaceutical production.
By replacing traditional heavy-metal catalysts with biocatalysts, Bio2Amine integrates seamlessly into existing manufacturing infrastructure while delivering enhanced precision, reduced energy consumption and improved sustainability.
Critically for API manufacturing, by replacing the precious metal catalyst with a bio-alternative, we expected to significantly streamline downstream processing burdens, to be fully verified in this program of work.
Project Scope and Objectives
This 12-month industrial-development project will focus on the manufacture of API Fampridine, scaling its production from Technology Readiness Level (TRL) 4 to TRL 7/8. The project’s developments will also serve as a blueprint for applying Bio2Amine technology to a broader range of APIs and intermediates, with 23 additional targets already identified.
Key Objectives:
Sustainable Manufacturing: Implement Bio2Amine for the production of Fampridine, reducing reliance on heavy-metal catalysts.
Cost and Carbon Efficiency: Track and report cost and carbon savings across, from enzyme production, chemical manufacturing and downstream processing.
Industry Benchmarking: Collaborate with Drochaid Research to compare Bio2Amine against state-of-the-art metal-catalysed processes.
Process Intensification: Optimise enzyme manufacturing and low-solvent systems to enhance efficiency and reduce environmental impact.
Regulatory and Commercial Readiness: Use sector experts to ensure compliance with industry standards, paving the way for commercial adoption.
Partnering for Success
Drochaid Research, an industry leader in catalyst screening and characterisation, will play a pivotal role in this project by:
Benchmarking Bio2Amine against existing metal-catalysed industrial processes for Fampridine manufacture,
Scaling HydRegen’s Bio2Amine-Fampridine process, and
Preparing Fampridine material for external quality control and assurance.
Additionally, expert-led sustainability, regulatory and commercialisation working groups – including key industry leaders such as Adrian Higson (NNFCC), Joe de Sousa (25+ years in Pharmaceutical manufacturing) and HydRegen Chair, Will Barton – will guide the project to ensure rigorous data collection, sustainability assessments and alignment with regulatory frameworks.
Expected Outcomes
By the end of this project, HydRegen and Drochaid will deliver a commercially viable, cost and carbon-competitive bio-manufacturing demonstrator for Fampridine, along with an industry-standard sustainability report and a manufacturing pack that includes a certificate of analysis.
Additionally, this project will identify and prioritise further opportunities for API and intermediate production, paving the way for broader implementation of Bio2Amine technology.
A Vision for the Future
The successful implementation of Bio2Amine will de-risk sustainable bio-manufacturing by demonstrating tangible CO2 and cost savings at scale. This will position HydRegen for widespread commercialisation in the pharmaceutical sector, enhancing the competitiveness of UK manufacturing and supporting the NHS with more cost-effective medicines.