The development of a live biotherapeutic product for clinical use, preventing NEC in preterm babies.

**BoobyBiome正在为微生物群受损的婴儿开发突破性的母乳衍生活生物治疗产品(LBPS)**。微生物组描述了包括细菌在内的微生物的集合，这些微生物居住在我们身上和体内。一个健康的微生物群在调节消化、免疫和代谢功能方面至关重要。母乳(HBM)贡献了婴儿肠道中40%的有益细菌。如果不能获得HBM，婴儿很容易患上与微生物组有关的疾病(坏死性小肠结肠炎、败血症、糖尿病、肠易激综合征等)。风险最大的是早产儿，这是英国新生儿死亡率最高的人群(占新生儿总数的8%)。尽管如此，早产疾病在医疗保健研究中仍然是一个资金不足的领域，对新疗法的需求很大。BoobyBiome正在开发一种世界第一的**多菌株**LBP，以降低标准干预措施的成本来改善早产儿的健康结果。我们的LBP将模仿HBM的微生物区系，通过补充这些婴儿所缺乏的细菌，将肠道恢复到健康状态。我们的产品将包含一个菌株群落，通过严格的科学测试和对HBM的精确表征而获得信息。**我们经过临床验证的多菌株LBP*将填补不断扩大的微生物组市场的未得到满足的需求**，目前的产品监管不力，含有来自婴儿粪便的最低限度的细菌菌株。通过这个项目，BoobyBiome旨在开发一种用于早产预防NEC的临床LBP产品。在该项目期间，多种临床相关菌株将被配制成概念验证LBP。随后，LBP将接受安全测试，并在专家监管、CMC和商业支持下扩大制造流程。完成这些里程碑的关键是我们的团队。BoobyBiome是一个由女性领导的团队，由具有创业专长的高素质科学家组成，他们的成功在于他们的不同技能组合。该团队的总部设在伦敦大学学院儿童健康研究所，与受人尊敬的婴儿微生物学家Bajaj-Elliott博士合作。协助该团队的是非执行董事大卫·福特和安德鲁·马丁(New Atlantis Ventures Ltd)，他们在早期科技企业方面拥有丰富的经验。此外，在英国生命科学投资界拥有良好记录的伊丽莎白·克莱恩提供战略和商业指导，并将帮助团队与现有投资者一起为未来的临床工作筹集资金。最终，BoobyBiome的目标是提供经过临床测试的商业产品，所有微生物群落受损的婴儿都可以获得，包括剖腹产和配方奶喂养的婴儿。我们致力于生产经过临床验证的LBPS，以在医疗保健部门实施真正的变革。

**BoobyBiome is developing breakthrough breast milk-derived live biotherapeutic products (LBPs) for infants with compromised microbiomes**. The microbiome describes the collection of microorganisms, including bacteria, which reside on and in us. A healthy microbiome is crucial in regulating digestive, immune and metabolic functions. Human breast milk (HBM) contributes 40% of the beneficial bacteria in an infant's gut. Without access to HBM, babies are vulnerable to microbiome-related diseases (necrotising enterocolitis (NEC), sepsis, diabetes, IBS etc.). Most at-risk are preterms, the largest population of neonatal mortality in the UK (8% of births). Despite this, preterm disease remains an underfunded sector in healthcare research, and there is a strong demand for new treatments.BoobyBiome is developing a world-first, **multi-strain** LBP to improve the health outcome of preterms at a reduced cost to standard interventions. Our LBP will mimic the microbiota of HBM, restoring the gut to a healthy state by replenishing the bacteria that these babies are lacking. Our product will contain a community of strains informed by rigorous scientific testing and precise characterisation of the HBM. **Our clinically validated multi-strain LBP** **will fill an unmet need in the expanding microbiome market**, with current products poorly regulated and containing minimal bacterial strains sourced from infant stool.With this project, BoobyBiome aims to develop a clinical LBP product for NEC prevention in preterms. During the project, multiple clinically relevant strains will be formulated to a proof-of-concept LBP. Subsequently, the LBP will be safety tested and manufacturing processes scaled up with expert regulatory, CMC and commercial support. The key to the completion of these milestones is our team. BoobyBiome is a female-led team of highly qualified scientists with entrepreneurial expertise whose success lies in their diverse skill sets. The team is based at the Institute of Child Health, UCL, collaborating with esteemed infant microbiologist Dr Bajaj-Elliott. Assisting the team are non-executive directors David Ford and Andrew Martin (New Atlantis Ventures Ltd), who have substantial experience in early-stage science and technology ventures. Further, ??Elizabeth Klein, with a proven track record in the UK's Life Sciences investment community, provides strategic and commercial guidance and will help the team raise funds alongside existing investors for future clinical work.Ultimately, BoobyBiome aims to deliver clinically tested, commercial products accessible to all babies with compromised microbiomes, including C-section and formula-fed babies. We are committed to producing clinically validated LBPs to exert real change in the healthcare sector.