About Us
Utilizing our years of experience in FMT treatment, manufacturing and our deep knowledge of the human microbiome allows us to provide you with high-quality FMT products using our highly-screening donor network and stringent manufacturing standards.
We are a Fecal Microbiota Transplantation (FMT) contract manufacturing organization specializing in creating high-quality FMT products to increase access to this revolutionary treatment. Our sole focus is to provide the best FMT products possible utilizing highly screened donors, a state-of-the-art microbiota lab, and stringent manufacturing standards. We strive to create FMT products that are safe, effective, and consistent.
At Novel Biome, we put the needs of our customers first and strive to provide them with the best possible experience. Our customers include researchers, clinicians, Physicians, institutions and clinics. We understand that FMT products are essential for our customers, and we make sure to provide them with the highest quality products and services.
We are proud of the work we do and the impact we have made in improving access to the best FMT products and services.
Our Mission
Our mission is to provide high-quality, safe fecal microbiota transplantation (FMT) products utilizing our expertise in FMT manufacturing and donor screening to support the clinical research and treatment needs of hospitals, clinics, researchers and physicians. Initially, Novel Biome was a company focused on providing access to FMT treatment for many patients who required medically supervised treatment. However, during this journey, we found that there existed a significant unmet need worldwide for available safe, high-quality FMT products. For this reason, we started producing our own FMT products, applying our very high standards to meet the growing need and demand.
FMT is gaining greater acceptance and interest today, especially following approvals for Clostridioides difficile infection. There is a growing need for high-quality FMT products to support hospitals, clinics, physicians and research organizations that are providing treatment and conducting research to prove FMT’s value in new indications. To support this shift in the field and ensure the best quality products are utilized, we at Novel Biome decided to transition our focus solely to the manufacturing of high-quality FMT products from our well-screened donor network to allow us to support a broader range of treatments and research and, in turn, giving us the opportunity to help even more people. We are dedicated to advancing the field of FMT and helping patients in need through our commitment to quality, safety, and efficacy.
Our Standards
Novel Biome was first founded to provide safe and effective FMT treatment, however it quickly became obvious to us that to ensure the best quality products for our patients, we would have to manufacture products ourselves in-house. With this drive to create the best possible FMT products, we formed a world class microbiota laboratory, and in collaboration with technical and scientific expertise, we significantly improved upon the FMT options available on the market.
After spending several years perfecting the FMT manufacturing process and investing significantly to ensure safe, effective and convenient FMT products, we have made the decision to move away from treatment to focus solely on FMT manufacturing, making our products available to a broader market to best support the growing need for this life-saving treatment.
Novel Biome provides four product formats, enema, colonoscopy, capsules and oral powder created in our specialized microbiota laboratory, which includes finished product testing. All our FMT products are created utilizing our highly-screened and vetted donor network, which exceeds industry standards.
References: 1. Kim, K. O. et al. 2019, 2. Jørgensen, S. M. D. et al. 2017, 3. Terveer, E. M. et al. 2017, 4. Mullish, B. H. et al. 2018, 5. Cammarota, G. et al. 2019, 6. Sokol, H. et al. 2016, 7. Carlson, P. E. 2020, 8. Cammarota, G. et al. 2017, 9. Bibbò, S. et al. 2020, 10. Edelstein, C. et al. 2016, 11. He, J. et al. 2021.