2025 ISPE FOYA Category Winner for Innovation

Executive Summary

Touchlight's Morelands facility, located in a historic Victorian waterworks building in Hampton, London, United Kingdom, has been transformed into a cutting-edge production facility for synthetic DNA technology "doggybone DNA" (dbDNA™). The facility tripled production capacity, making it one of the largest DNA manufacturing sites in the world. The dbDNA™ platform addresses challenges associated with traditional plasmid DNA (pDNA) manufacturing by eliminating the need for fermentation, antibiotic resistance sequences, or plasmid extraction, achieving higher purity and greater sequence flexibility.

This submission was awarded ISPE Facility of the Year Awards (FOYA) Category Winner recognition in the Innovation category for its groundbreaking approach to DNA manufacturing. The dbDNA™ platform utilizes an enzymatic process that significantly reduces production timelines, enhances purity, and offers greater sequence flexibility compared to traditional methods. This innovative approach enables rapid production of DNA at scales suited for genetic medicines. Additionally, the facility's transformation of a historic building into a state-of-the-art GMP manufacturing site was a key factor in receiving FOYA recognition. This unique blend of heritage and innovation not only preserves a piece of London's industrial legacy but also equips it for the complexities of modern DNA manufacturing.

Innovation

Touchlight's proprietary dbDNA™ platform is a fully synthetic, linear DNA vector produced enzymatically. The process leverages rolling circle amplification (RCA) powered by enzymes to rapidly synthesize large quantities of DNA. This innovative approach not only achieves higher purity and greater sequence flexibility but also facilitates expedited DNA production to support the development of genetic medicines, including mRNA vaccines, and viral vectors (e.g., adeno-associated viral vectors and lentiviral vectors), and gene therapies.

Operations

The Morelands facility is designed for flexibility and scalability, supporting advanced DNA-based therapeutic areas such as genome editing, DNA vaccines, and non-viral gene therapy. The modular layout allows for simultaneous manufacturing of multiple products. The facility employs single-use systems, reducing contamination risks and simplifying the scale-up process.

Supply Chain

Touchlight implemented SAP S/4HANA Cloud to streamline operations, improve traceability, enhance efficiency, and support future expansions. This digital transformation earned Touchlight the Business Innovator Award in the SAP UKI Customer Success Awards 2024. The new system has allowed the business to support prospective customer audits by demonstrating that robust processes, data, and standards are in place.

Social Impact

The dbDNA™ technology incorporates green manufacturing techniques, reducing water and energy consumption, and enabling rapid deployment to respond to health crises. Touchlight received funding from the Bill & Melinda Gates Foundation to apply its technology for pandemic responses.

Safety Considerations

Safety was a top priority throughout the project. A collaborative approach between Touchlight personnel and on-site contractors was vital for maintaining safety standards. The project achieved an exemplary safety record with zero reportable incidents over the 24-month period, with a Lost Time Incident Rate (LTIR) of zero and a Recordable Incident Rate (RIR) of zero, reflecting a strong commitment to safety culture.

Sustainability Efforts

The facility employs sustainable practices, such as reduced footprint, benchtop equipment, shorter batch durations, and reduced water usage. Electricity is procured through a green energy tariff, ensuring sustainable energy usage across the site.

For all the reasons listed above, Touchlight is recognized as the 2025 ISPE FOYA Category Winner for Innovation.

Supply Partners and Key Participants:

Manufacturer/Owner Name: Touchlight

Main General Contractor: WHP Engineering

Engineer/Architect (A&E): Chapman Architects

Commissioning Qualifications & Validation Services: CTS Limited

Construction Manager: WHP Engineering

Piping Subcontractor: WHP Engineering

HVAC Subcontractor: WHP Engineering

Process Equipment Supplier:

• Repligen
• Cytiva/Global Life Sciences Solutions Operations UK Ltd
• Thermo Fisher Scientific/Life Technologies BPD UK Ltd

Major Equipment Supplier:

• Evolve Consulting Engineers (Structural Engineering)
• Bloomsbury Proiect Management (Project Manager)
• Velovoce (Project Manger)
• Watson Marlow
• Haier Biomedical (Biosafety Cabinets)
• BINDER GmbH (Incubators)