FAQ

FAQ

At Novel Biome, we are dedicated to transparency and knowledge transfer. Explore our FAQ section to gain insights into FMT and Novel Biome’s commitment to high-quality, on-demand FMT products. If you have inquiries beyond what's covered, our team is ready to assist.

<p>To place an order, a member of your clinical and/or research team must complete a clinical partner <a href="https://www.novelbiome.com/user/account/register"><strong>registration form</strong></a>. We require each location we ship to have completed our clinical registration form.</p>

<p>We provide four formation options, including capsules, enemas, colonoscopy, and oral powders created under our Health Canada Drug Establishment Licence (DEL) in our specialized GMP-certified microbiota lab, which includes in-house finished product testing. Our <a href="https://www.novelbiome.com/fmt-product"><strong>FMT Products</strong></a> utilize our highly-screened donor network, which exceeds industry standards.</p>

<p>At Novel Biome, we take safety, quality, and stringent manufacturing standards seriously and keep these factors in mind at every step of the manufacturing process. We break our manufacturing into 3 steps:</p><ol><li>Donor screening and stool collection: The primary focus of donor screening is to increase the safety of FMT by excluding known pathogens1–4. Donor screening is designed to minimize the risk of transmitting potentially infectious diseases or contagious traits from donor to recipient1–4. To determine a donor’s health, various types of screening are performed, including health and wellness questionnaires, blood testing, and stool testing1,2,5-11. Generally, most potential donors are excluded during initial screening, and samples and donors are regularly tested to reduce risks 12-15.</li><li>Manufacturing process: At Novel Biome, stool is processed on-demand in our state-of-the-art microbiome laboratory, which has stringent policies and Standard Operating Procedures. Our lab and processes follow Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).</li><li>Storage and administration: All our finished products are in a temperature-controlled environment. All our FMT products, capsules, dried powder, colonoscopy and enemas are freeze-dried, so they can be transported without being frozen and stored long-term at 4 degrees Celsius. Novel Biome is currently performing long-term stability tests in-house to ensure the best storage conditions are used to preserve the FMT products.</li></ol><p><br>&nbsp;</p><p>Reference: 1. Jørgensen, S. M. D. et al. 2017, 2. Woodworth, M. H. et al. 2017, 3. Woodworth, M. H. et al. 2017, 4. Lagier, J.-C. 2014, 5. Terveer, E. M. et al. 2017, 6. Cammarota, G. et al. 2017, 7. Cammarota, G. et al. 2019, 8. Sokol, H. et al. 2016, 9. Mullish, B. H. et al. 2018, 10. Bakken, J. S. 2009, 11. Kelly, C. R. et a. l2015, 12. Nakov, R. et al. 2021, 13. Kassam, Z. et al. 2019, 14. Paramsothy, S. et al. 2015, 15. Hota, S. S. et al. 2019.</p>

<p>All our finished products are stored in a temperature-controlled environment. All our FMT products are freeze-dried, so they can be transported without being frozen and stored long-term at 4 degrees Celsius. Novel Biome is currently performing long-term stability tests in-house to ensure the best storage conditions are used to preserve the FMT products</p>

<p>Yes, all our shipments are via UPS, and a tracking number will be provided.</p>

<p>Novel Biome utilizes freeze-drying to create all of our formulations, extending the stability of our products. Our products are stable in a 4-degree Celsius environment for up to 2 years. We are currently undertaking in-house stability testing to see if our products remain viable for even longer periods.</p>

<p>We are committed to upholding the highest quality and safety standards in our manufacturing processes. We have implemented strict quality control measures, including rigorous testing and inspections, to ensure that our products meet or exceed all applicable regulations and industry standards..</p>

<p>If you are interested in becoming a donor for FMT, <a href="https://novelbiomedonor.com/"><strong>please visit our donor page</strong></a> to read more about becoming a donor and take our eligibility quiz. Donors must undergo a thorough screening process to ensure they are healthy and free of infectious diseases or traits that could be transmitted through FMT.</p>