We require all clinical partners that utilize our FMT products to report all adverse events (AEs) to Novel Biome and, if needed, their regulatory health body. File a Report

We provide four formation options, including capsules, enemas, colonscopy and oral powders. Our FMT products utilize our highly-screened donor network, which exceeds industry standards. Our products are designed to be safe, effective, and easy to use and can be customized to meet the needs of our customers. FMT Products

At Novel Biome, we take safety, quality and stringent manufacturing standards seriously and keep these factors in mind through every step of the manufacturing process. We break our manufacturing into 3 steps:

1. Donor screening and stool collection: The primary focus of donor screening is to increase the safety of FMT by excluding known pathogens. Donor screening is designed to minimize the risk of transmitting potentially infectious diseases or contagious traits from donor to recipient. To determine a donor’s health, various types of screening are performed, including health and wellness questionnaires, blood testing, and stool testing. Generally, most potential donors are excluded during initial screening, and samples and donors are regularly tested to reduce risks.
2. Manufacturing process: At Novel Biome, stool is processed in our state-of-the-art microbiome laboratory, which follows all regulatory guidelines and has stringent policies and Standard Operating Procedures.
3. 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.

All our finished products are a temperature controlled environment. All our FMT products, capsules, dried powder, colonosocpy 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

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

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.

Our company has extensive experience in both FMT treatment and manufacturing. Our team has performed hundreds of FMT procedures on patients, and we have focused on creating the highest-quality FMT while developing rigorous manufacturing and safety standards. We have recently moved away from directly treating patients to focus solely on FMT product manufacturing in our specialized microbiota laboratory and manufacturing space. We believe that focusing on manufacturing high-quality FMT products is the best way for us to make a greater impact in the field of FMT.

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..

If you are interested in becoming a donor for FMT, please visit our donor page 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.