Notice

Engineering Biology Sandbox Fund: successful projects

Updated 18 November 2025

Round 2: successful project

Selected project from round 2 of the Engineering Biology Sandbox Fund that ran from 29 April 2025 to 18 July 2025.

Multi-Agency Regulatory Groundwork for Engineered Phage Regulatory Sandbox 

• Funding amount: £921,246 
• Partner: Medicines and Healthcare products Regulatory Agency (MHRA)

Project description

The Medicines and Healthcare products Regulatory Agency (MHRA) will run a cross-sector regulatory sandbox to address critical gaps in the regulation of engineered bacteriophage (phage) products across One Health, working collaboratively with veterinary, food, environment and health security regulators and supported by academic and industry experts.  

Antimicrobial resistance threatens to reverse decades of progress in medicine, food production, and public health. Phages are viruses that target and destroy bacteria. They are gaining attention as potential solutions for the challenge of antimicrobial resistance as well as other difficult to treat infections and vulnerable patient groups. Safe and effective engineered phage products could alleviate threats to food security, animal welfare, and human health from antibiotic-resistant microorganisms.    

Lack of regulatory clarity negatively impacts innovation and investment and delays access to products which could contribute to our biosecurity. Coordinated regulatory frameworks that are enabling and risk appropriate are vital; this regulatory sandbox will deliver clear pathways to market approval, make the UK attractive to innovators, and enable early access to novel products.  

The MHRA will coordinate efforts for this sandbox project across 5 regulatory agencies:

• UK Health Security Agency
• Food Standards Agency
• Veterinary Medicines Directorate
• Department for Environment, Food and Rural Affairs

to define how these products should be assessed, approved, and adopted.

Support from academic experts at the Quadram Institute will support this work, and the work will be informed through open dialogue with the innovator community.  

This sandbox project will result in the development of regulatory guidance, reference materials and accessible toolkits appropriate for innovators and will establish the UK as a global leader in responsible phage innovation.

Lawrence Tallon, MHRA Chief Executive said:  

Antibiotic resistant “superbugs” are estimated to cause 1.2 million deaths a year worldwide – and that number is predicted to reach 10 million by 2050 unless we find new ways of killing these superbugs. Antibiotic resistance threatens to turn back the clock back on modern medicine and our ability to treat everyday infections, as well as threatening food production and overall biosecurity.  

Innovative solutions, such as engineered bacteriophages, offer great promise in addressing this looming crisis. To realise their full potential, we must ensure these technologies are developed safely and responsibly, within a clear regulatory framework. 

Working hand in hand with our key partners, we aim to get safe and effective phage products to patients, farmers and food producers quickly, bridging regulatory gaps, and providing clarity for innovators – all while maintaining the highest standards of safety and public confidence.

Round 1: successful project

Selected projects from round 1 of the Engineering Biology Sandbox Fund that ran from 1 February 2024 to 19 April 2024.

Food Standards Agency Cell-Cultivated Product Regulatory Sandbox

• Funding amount:£1,600,000.00
• Partner: Food Standards Agency (FSA)

Project description

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) cell-cultivated product (CCP) sandbox will support innovation through safety. CCPs are foods created through the isolation of cells from meat, seafood, fat, offal or eggs which are grown in a controlled environment and harvested to create consumer food products.

Through the sandbox we will gather rigorous scientific evidence about cell-cultivated products and the technology used to make them. This information will enable us to make well-informed decisions about product safety. It will also allow us to better guide companies on how to make products in a safe way and how to demonstrate that these products are safe.  As part of the sandbox, we’ll be able to offer pre-application support to CCP companies and address key questions that must be addressed before CCPs can enter the market, for example around labelling.

This work will mean we can process CCP applications more quickly and support businesses better in their applications, ultimately providing consumers with a better choice of safe foods. The work achieved by the sandbox will also allow the FSA and FSS to keep pace with emerging technologies and apply new insights when authorising other innovative foods.

The programme will reduce delays and costs associated with applying for regulatory approval- estimated at the date of publication to be £350,000-£500,000 per company per product- and will help CCP companies attract the investment they need to scale-up production.

Professor Robin May, Chief Scientific Advisor at the FSA said:

Ensuring consumers can trust the safety of new foods is one of our most crucial responsibilities. The CCP sandbox programme will enable safe innovation and allow us to keep pace with new technologies being used by the food industry to ultimately provide consumers with a wider choice of safe foods.