FBT have established a close and long-term strategic partnership. By combining the strengths of all three parties in research, manufacturing, and commercialization, the alliance aims to advance exosome-related products from the “research-grade” stage toward “clinical and industrial-grade” applications. Through this strategic collaboration, Foundation Biotech will use SonoBio’s products as the core platform material, integrating Rapha Biotech Limited’s manufacturing and technology transfer capabilities to build a scalable and sustainable exosome product pipeline that covers multiple application areas, including skin and tissue regeneration, beauty and anti-aging, inflammation and immune modulation, and other potential clinical indications.
Learn more about Foundation Biotech’s work in regenerative medicine, epigenetics, and exosome education, including expert insights, course information, and explanations of cutting-edge research.
FBT has established a close and long-term strategic partnership with Rapha Biotech and Sonobio, combining the three parties’ strengths in scientific research, manufacturing and commercialization to promote the application of exosome-related products from “research grade” to “clinical and industrial grade”
Through this strategic alliance, the three parties will use standardized, high-quality exosomes as the core platform to establish a complete translational pathway from the laboratory to the clinic and the market.
Roles and Key Strengths.
- Foundation Biotech:Responsible for clinical analysis, product strategy, and application design, connecting outcomes with real-world medical.
- Rapha Biotech:Provide exosome manufacturing & technology transfer capabilities compliant with FDA standards, supporting process scale-up and QC.
- SonoBio:Deliver high-purity, high-stability exosome products as a material for diverse applications in regenerative medicine and synthetic biology.
Exosome Product Pipeline Planning
FBT will use Sonobio's products as core platform materials, combined with Rapha Biotech's manufacturing and technology transfer capabilities, to build a sustainable and scalable exosome product pipeline.
- Gradually transition from research-grade products to preclinical and clinical-grade applications.
- Establish a reproducible and scalable manufacturing and quality standards system.
- Maintain flexibility for future expansion into additional indications and product formats.
Key Application Areas
- Skin and Tissue Repair:For use in wound repair, and mucosal and soft tissue regeneration.
- Beauty and Anti-Aging:Support high-end medical aesthetic solutions for skin quality enhancement, collagen remodeling, and anti-photoaging.
- Inflammation and Immune Modulation:Explore potential applications in diseases associated with chronic inflammation and immune dysregulation.
- Other Potential Clinical Indications:Including fibrosis-related diseases, tissue and organ functional recovery, and other frontier areas.
Exosome Production
Rapha Biotech has a cGMP (current Good Manufacturing Practice) production system, providing end-to-end quality control for Sonobio™ exosome products from raw material selection and cell culture through purification, separation, and lyophilized packaging.
Core Manufacturing Advantages:
- 300 billion Particles per Bottle - High‑conc lyophilized exosomes suitable for research and clinical development use.
- Aseptic Manufacturing Environment - Compliant with 21 CFR Parts 210 and 211, ensuring product safety.
- Stringent Quality Tests - Including sterility and endotoxin testing, mycoplasma screening, and consistency verification.
- Traceable Batch Management - Each batch is accompanied by a complete Certificate of Analysis (COA).
Our facilities are equipped with bioreactors, ultracentrifugation systems, lyophilization equipment, and cleanroom environments, and we are continuously expanding our cGMP certification scope to build a solid foundation for future clinical and commercial applications.
Four Key Directions
Sonobio™ exosomes, with their multifunctionality and biocompatibility, are showing strong potential in regenerative medicine, medical aesthetics, and clinical therapeutics. Through their strategic alliance, Foundation Biotech, Rapha Biotech, and SonoBio are committed to advancing this cutting-edge technology from the laboratory into clinical practice and the marketplace.
1. Tissue Regeneration
Exosomes promote collagen synthesis and fibroblast activation, accelerating wound healing and tissue repair, and are suitable for applications such as skin injury, mucosal repair, and soft tissue regeneration.
2. Anti-Aging
By delivering anti-aging factors and regulating miRNA, exosomes can improve photoaging damage and strengthen the collagen matrix, providing a scientific foundation for high-end medical aesthetics and functional skincare.
3. Immune Modulation
Exosomes can regulate macrophage polarization from M1 to M2, reduce pro‑inflammatory cytokines, and restore immune homeostasis, offering potential adjunct therapeutic value in chronic inflammatory and autoimmune diseases.
4. Clinical Therapy
A clinical trial program targeting fistula treatment in Crohn’s disease is currently being advanced, while engineered exosomes loaded with anti-fibrotic miRNAs (such as miR‑29 and miR‑132) are being explored to inhibit fibroblast activation and reduce scar formation, offering innovative solutions for refractory diseases.
