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

**BoobyBiome正在开发突破性的母乳衍生活生物治疗产品（lbp），用于治疗微生物组受损的婴儿**。微生物组描述了居住在我们身上和体内的微生物的集合，包括细菌。健康的微生物群对调节消化、免疫和代谢功能至关重要。母乳（HBM）贡献了婴儿肠道中40%的有益细菌。如果无法获得HBM，婴儿很容易患上微生物组相关疾病（坏死性小肠结肠炎（NEC）、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（占新生儿死亡率的8%）。尽管如此，早产疾病仍然是医疗保健研究中资金不足的部门，对新治疗方法的需求强烈。BoobyBiome正在开发一种世界首创的多品系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的微生物群，通过补充这些婴儿缺乏的细菌，将肠道恢复到健康状态。我们的产品将包含一个由严格的科学测试和HBM的精确表征通知的菌株社区。**我们临床验证的多菌株LBP** **将填补不断扩大的微生物组市场的需求**，目前的产品监管不佳，含有来自婴儿粪便的细菌菌株最少。通过这个项目，BoobyBiome旨在开发一种用于早产儿NEC预防的临床LBP产品。在项目期间，多个临床相关菌株将被配制成概念验证的LBP。随后，LBP将进行安全测试，并在专家监管、CMC和商业支持下扩大生产流程。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高素质科学家团队，他们具有创业专业知识，成功在于他们的多样化技能。该团队位于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。协助团队的非执行董事David Ford和Andrew Martin (New Atlantis Ventures Ltd)，他们在早期科学和技术投资方面有丰富的经验。此外,? ?Elizabeth Klein在英国生命科学投资界有着良好的业绩记录，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的目标是为所有微生物组受损的婴儿提供经过临床测试的商业产品，包括剖腹产婴儿和配方奶粉喂养的婴儿。我们致力于生产临床验证的lbp，以在医疗保健领域发挥真正的变化。

**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.