Fecal microbiota transplantation (FMT) is recognized as a very effective, first-line treatment indicated for the treatment of pseudomembranous enterocolitis, which is a disease characterized by inflammation of the colon as a result of Clostridium difficile (C.diff) infection. This infection is a common cause of deadly diarrhea after antibiotic use, which according to the CDC kills ~30,000 patients per year. In the last 10 years, FMT has gained a lot of interest and acceptance in both the scientific and medical communities with demand for broader treatment access coming from the general population.
Comprehensive FMT donor screening and Lab testing and process manufacturing are critical to the quality and safety of the final FMT product and thus make it very expensive. FMT manufacturing presents further challenges with regard to locating a suitable Lab space. This frequently results in treating physicians’ using research space to manufacture a clinical therapeutic. Lab-based expertise with regard to donor manufacturing techniques, and needed equipment is extremely important.
For this reason, a critical component of medically supervised FMT treatment is utilizing a “state of the art” lab facility for product manufacturing and testing as well as appropriate and adequate donor screening. At Novel Biome™, we make this our priority whereby we follow the highest regulatory and association donor screening standards to ensure the highest quality product. All of our donors undergo routine screening for both blood and stool-borne pathogens. Before becoming a donor, they undergo this rigorous serologic and stool testing and screening and then again on a routine basis to ensure all collected and processed materials are safe to be implanted. In addition to extensive laboratory analysis, the donor’s medical background and health history are pivotal in determining whether or not they would make a suitable donor. All 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.
With regard to the Lab, it is extremely important and necessary that the very high standards of Good Laboratory Practice (GLP) be followed for the manufacturing of FMT products. At Novel Biome™ we employ these very high standards. At a high level, this involves the following:
- The construction of our Lab facility and Lab Equipment in the facility
- Our Test Systems and Testing Processes
- Our Manufacturing Process and associated standard operating procedures (SOPs)
- Our approach to Quality Assurance and our Adverse Event Reporting
To appreciate the commitment we have made to FMT manufacturing, you can see some photos of our brand-new custom-built state-of-the-art lab facility by going HERE.
Our primary treatment focus at Novel Biome is in supporting autistic children who suffer from digestive symptoms and significant microbiome imbalance to restore their microbiome through FMT. You can learn more about our approach to treatment by going here.
Team Novel Biome