Fecal microbiota transplantation (FMT) is an approved and very effective treatment for patients with recurrent Clostridium difficile infections (rCDI) who are non-responsive to antibiotic therapy ^1–6.  In the last 10 years, FMT has gained much interest in both the scientific and medical communities with a demand to understand better how modifications of the gut microbiome using FMT can improve health and tackle areas of unmet medical need for both gastrointestinal (GI) and non-GI disorders ^1,7–10.

As the use of FMT grows and the efficacy of FMT is further supported in areas outside of rCDI ^1,7–10, the importance of safety becomes further highlighted ^11–17. The most critical components to ensure safety during the FMT process are the application of comprehensive donor screening and high-quality product manufacturing.  

Donor screening

The primary focus of Donor screening is to optimize the safety of FMT by excluding known pathogens ^18–21. Donor screening is designed to minimize the risk of transmitting potentially infectious diseases or contagious traits from a donor(s) to a patient ^14,18.  To determine a donor’s health, various types of screening are performed, including health and wellness questionnaires and blood and stool testing ^{12,14–19,22,23}. A donor’s medical background and health history are pivotal in determining whether they would make a suitable donor and helps to exclude issues not detectable through blood and stool screening ^12,14,15.  This initial screening examines the risk of infectious diseases, the history of disorders potentially associated with dysfunction of the gut microbiota and the use of treatments and/or medications that can affect the gut microbiota ^14,15,17. Generally, initial screening excludes a majority of potential donors, with studies suggesting that between 50-and 90% are excluded after medical evaluation ^24,25.

At Novel Biome, we use more stringent initial screening, going above and beyond all published standards ^{12,14–19,22,23}! Specifically, all Novel Biome donors are vaginally born, breastfed, active, physically fit, and have never received antibiotics in their lives. Additionally, they eat a diverse omnivorous diet to ensure as much bacterial diversity as possible.

Donors not excluded after the initial health and wellness screening undergo extensive laboratory analysis of blood and stool ^14,15. Comprehensive laboratory analysis is paramount to the safety of FMT and helps to identify potential pathogens possibly transmissible during FMT to reduce risks to patients ^12,14,15.  At Novel Biome, we use 120 different testing parameters to evaluate blood and stool for things including parasites, viruses, fungi, and active infections to ensure the safety of all FMT products, with testing repeated regularly.  

High-quality product manufacturing

Incorporating pharmaceutical-grade laboratory spaces, equipment and production standards is critical to ensure the quality and safety of final FMT products but does make the process expensive ^14,16–18. The creation of pharmaceutical-grade laboratory space is often limited by the ability to locate a suitable laboratory space, find high-quality and trained personnel and create stringent and consistent manufacturing processes ^14,16–18. While these are high barriers to overcome, expertise in donor manufacturing techniques and the use of proper equipment are critical ^14,16–18. At Novel Biome laboratory and manufacturing space follows all Good Laboratory Practices (GLP), and we are currently in the process of being Health Canada DEL and Good Manufacturing Practices (GMP) certified. We understand the importance of manufacturing under stringent standards to create consistent, safe and scalable high-quality FMT products. 

With regard to FMT manufacturing, it is essential and necessary that the highest standards of Good Laboratory Practice (GLP) are followed for the manufacturing of FMT products.  To ensure the Quality, Safety and Consistency of our FMT products we place the highest stands on:

• Hiring the Very Best Lab Personnel
• Purchasing the Best Facility and Laboratory Equipment
• Ensuring our Test Systems and Processes are Optimal
• Exceptional Manufacturing Processes, Quality Assurance and Standard Operating Procedures
• Stringent Donor Screening, Blood, and Stool Testing
• Adverse Event Reporting

At Novel Biome, safety is our #1 priority. We continually evaluate our safety measures, and all donor screening requirements as science and regulations progress and new information becomes available. We prioritize quality and safety in every aspect of our operations, and our commitment to producing high-quality FMT products is reflected in the creation of our specialized and purposed-built microbiome laboratory. 

At Novel Biome, we're passionate about the importance of the gut microbiome and the transformative potential of Fecal Microbiota Transplantation (FMT) treatment to restore health. As an FMT contract manufacturer, we leverage our years of experience in FMT to manufacture high-quality FMT products utilizing our highly-screened donors and stringent manufacturing standards. If you are interested in learning more about our FMT products and manufacturing capabilities, please contact us HERE or to register as a clinical partner to order FMT products, click HERE.

References:  1. Allegretti, J. R. et al. 2019, 2. Cammarota, G. et al. 2015, 3. Kao, D. et al. 2017, 4. Lee, C. H. et al. 2016, 5.  Lee, C. H. et al. 2019, 6.  van Nood, E. et al. 2013, 7. Brandt, L. J. & Aroniadis, O. C. 2013, 8.  Choi, H. H. & Cho, Y.-S. 2016, 9.  Rinott, E. et al. 2021, 10. Xu, M.-Q. 2015, 11. Kim, K. O. et al. 2019, 12. Terveer, E. M. et al. 2017, 13. Carlson, P. E. 2020, 14. Cammarota, G. et al. 2017, 15. Cammarota, G. et al. 2019, 16. Sokol, H. et al. 2016, 17. Mullish, B. H. et al. 2018, 18. Jørgensen, S. M. D. et al. 2017, 19. Woodworth, M. H. et al. 2017, 20. Woodworth, M. H. et al. 2017, 21. Lagier, J.-C. 2014, 22. Bakken, J. S. 2009, 23. Kelly, C. R. et al. 2015, 24. Kassam, Z. et al. 2019, 25. Paramsothy, S. et al. 2015.