By: Dr. Shaina Cahill, Ph.D. (Director Medical Communications & Affairs)
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.
We use more stringent initial screening, going above and beyond all published standards 12,14–19,22,23! Specifically, all our 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. 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. For this reason, an essential component of our medically supervised FMT treatment is utilizing our new “state of the art” laboratory facility for product manufacturing and testing!
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. We employ these standards, which involve:
o The construction of our lab facility and high-end lab equipment
o Hiring high-quality and trained lab personnel
o Ensuring our test systems and processes are optimal
o Optimizing our manufacturing process and standard operating procedures (SOPs)
o Quality assurance and our adverse event reporting system
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 ensure that we manufacture the highest quality product we can in our pharmaceutical-grade laboratory facility and employ stringent donor screening.
At Novel Biome, we believe in the importance of the gut microbiome for overall health and the possibilities of fecal microbiota transplantation (FMT) to restore gut health and treat disease. Novel Biome focuses on FMT product manufacturing and supplying high-quality products, relying on our world-class donors to allow us to make a significant difference in the lives of many individuals, take our eligibility quiz to see if you can be a stool donor.
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.
