Medicines & Healthcare Products Regulatory Agency (MHRA) Approved FMT Manufacturing Facility

FMT Manufacturing Specialists and Pioneers

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Role of Gut Flora


The gut flora, also known as the gut microbiota or microbiome, refers to the diverse community of microorganisms that inhabit the gastrointestinal tract, primarily the colon. These microorganisms include bacteria, viruses, fungi, and other single-celled organisms. The role of gut flora in the human body is multifaceted and essential for maintaining various aspects of health. Some key roles of gut flora include;

    1. Digestion and Nutrient Absorption: Gut flora play a crucial role in breaking down complex carbohydrates, proteins, and fats that are not digestible by human enzymes. They produce enzymes that help digest these substances, facilitating the extraction of nutrients from food.
    2. Immune System Regulation: Gut flora interact closely with the immune system, influencing its development and function. They help train the immune system to distinguish between harmful pathogens and beneficial microorganisms, thereby promoting immune tolerance and preventing inappropriate immune responses.
    3. Protection Against Pathogens: Gut flora compete with harmful microorganisms for space and nutrients within the gut, thereby preventing the colonization and growth of pathogens. They also produce antimicrobial substances that inhibit the growth of harmful bacteria, viruses, and fungi.
    4. Synthesis of Vitamins and Short-Chain Fatty Acids: Certain species of gut bacteria produce vitamins such as vitamin K, biotin, and folate, which are essential for various metabolic processes in the body. Additionally, gut flora ferment dietary fibers and produce short-chain fatty acids (SCFAs) like acetate, propionate, and butyrate, which serve as an energy source for colon cells and have numerous other health benefits.
    5. Metabolism and Weight Regulation: Gut flora influence the metabolism of dietary compounds and drugs, potentially affecting their absorption, distribution, and elimination in the body.
    6. Brain-Gut Axis Communication: Emerging research suggests that the gut microbiota can communicate bidirectionally with the central nervous system through various pathways, such as the vagus nerve and the production of neurotransmitters and neuroactive compounds. This communication plays a role in regulating mood, behavior, and cognitive function.
    7. Maintenance of Gut Barrier Function: Gut flora contribute to the integrity of the intestinal barrier, which helps prevent the leakage of harmful substances from the gut into the bloodstream. They promote the production of mucus and tight junction proteins, which form a physical barrier against pathogens and toxin.

Overall, the gut flora play a vital role in maintaining gut health, supporting overall immunity, regulating metabolism, and influencing various aspects of human health and disease.


About Us

TML.Science® is Britain’s first independent manufacturer of FMT products, supplying medical professionals with the highest quality microbiome.

TML.Science® manufactures Faecal Microbiota Transplant (FMT) products for treatment administered by medical professionals. was established in 2003 with the vision of addressing and improving gut health.

In 2011 began manufacturing FMT products and has been committed to improving the quality of FMT products to the highest standards. In 2018, the Medicines & Healthcare Products Regulatory Agency (MHRA) recognised FMT as a medicinal product and as such it must be regulated by MHRA in the UK. began the accreditation process and filed the Manufacturing Specials (MS) licence application in May 2020, achieving MHRA accreditation in March 2021. manufactures FMT products in accordance with good manufacturing practices (GMP) standard. updated its vision to focus solely on manufacturing FMT products under UK MHRA regulations, to set the gold standard for the industry and to be world renowned for safety and quality.

The qualified and highly experienced professionals at strive to provide the best services to the healthcare industry.


How We Manufacture FMT Products

TML.Science® utilise the best manufacturing processes to ensure clean and safe FMT products.

We manufacture FMT products using fresh donations each day from screened and approved donors. Fresh stool donations are processed within 6 hours to capture as many live micro-organisms as possible in the finished product. During the manufacturing process, we remove the unnecessary waste materials that would not provide benefit to the end user. The finished FMT product is a 30ml concentrated extract of the human lower gut microbiome.

Our FMT products are:

  • Stored in ultra-low freezers at -85°C.
  • Removed from unnecessary waste materials such as undigested food, dead cells, mucus, solid debris, water, salt, fibre, fat to achieve the highest level of purification possible.
  • Quarantined for at least 90 days prior to being released, ensuring there are no slow-to-show infections in our donors.
  • Tested for most common pathogens in the stool via stool PCR analysis.
  • Tested for Covid-19 in the stool via RNA extraction and RT-PCR analysis.
  • Tested for various targets in the blood sample of the donor.


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Our donors

Healthy diversity from our donors is key to providing Faecal Microbiome Transplants (FMT).

Healthy diversity from our donors is key to providing the best FMT products. Our donors live in the local area and develop a relationship with whereby we know our donors very well and we continuously monitor their health and wellbeing.

Our donors undergo a strict multi-stage screening process prior to becoming an approved donor, and once approved they undergo monthly stool tests and quarterly blood tests as a minimum. With this process we achieve safe, high quality FMT products.

Please follow the link to discover more about our screening process.