10103354Developing clinically efficacious breast milk-derived microbiome supplements for infants.ActiveCollaborative R&DInnovate UK**BoobyBiome is developing a breakthrough breast milk-derived synbiotic for infants with compromised microbiomes.** The microbiome describes the microorganisms which reside on and in us. A healthy microbiome is crucial in regulating digestive, immune and metabolic functions. **Human breast milk (BM) contributes 40% of the beneficial bacteria in an infant's gut**; without it, babies are vulnerable to microbiome-related diseases (necrotising enterocolitis (NEC), sepsis, diabetes, IBS, etc). The **first-of-its-kind**, consortia symbiotic will contain **BM-derived probiotic bacteria** supplemented with a blend of **5 prebiotic human milk sugars**, mimicking BM. Strains are selected through rigorous testing and precise BM characterisation. Current products are poorly regulated, containing limited strains sourced only from infant stool; our **next-generation multi-strain symbiotic** will fill an unmet need in the expanding microbiome market, improving the health outcomes of infants at a reduced cost to standard interventions. With this project, BoobyBiome aims to: 1. Establish our synbiotic's **impact on microbial community dynamics** (relative abundance shifts and metabolite production) in formula-fed infant guts, using _in silico_ and _in vitro_ models. 2. Develop a **QC method to quantify the abundance of each bacterial strain** within the synbiotic (testing qPCR and ddPCR) 3. Develop a **GMP-grade liquid-formulation process**, generating transferable knowledge to pivot in the future to Live Biotherapeutic Product development. 4. Complete **regulation, ethics and clinical trial designs** to demonstrate synbiotic efficacy in formula-fed infants. This project will support our ultimate aim: to become the **first synbiotic to achieve a health claim from EFSA.** The key to meeting this project milestones and health-claim status is our team. BoobyBiome is a **female-led team** of **highly qualified scientists** with **proven business expertise** and **diverse skill sets**, based at the Institute of Child Health, UCL, in collaboration with esteemed infant microbiologist Dr Bajaj-Elliott. Assisting the team are non-executive directors Neil Clark (former CEO of Destiny Pharma) and Helen O'Neill (CEO of Hertility) who have substantial experience in developing bacterial therapeutics and launching female health-focused products to market. This project will also allow us to **forge a collaborative partnership** with the Gut Immunology & Microbiology team at the University of Reading. They boast **20+ experience in gut health research** and will provide invaluable insights as our synbiotic R&D continues. Ultimately, BoobyBiome aims to **provide clinically verified, efficacious products accessible to all babies with compromised microbiomes**. Our unwavering commitment is to develop rigorously tested live bacterial products that will affect real change in the healthcare sector.