Welcome to TML.science
Medicines & Healthcare Products Regulatory Agency (MHRA) Approved Faecal Microbiota Transplant (FMT) Manufacturing Facility
FMT Manufacturing Specialists and Pioneers
TML.science at a Glance
Regulatory Compliance
Fully compliant with UK MHRA standards
Stringent Quality Management System (QMS)
MHRA Manufacturer’s Specials (MS) Licence and Manufacturer’s Authorisation (MIA) Licence
Proven Expertise
Pioneers of FMT manufacturing since 2012
Safe
Minimum 3-month quarantine period
Continuous monitoring of donors
Strict donor screening process
Global Reach
International collaboration across Europe and The Bahamas
Dedicated Staff
Highly skilled staff with over 10 years’ experience
Our Vision & Values
At TML.science, we are committed to advancing healthcare via Faecal Microbiota Transplant (FMT). Our goal is to provide safe, effective, and scientifically backed treatments that improve patient outcomes and restore gut health, contributing to the growing field of microbiome-based treatments.
Quality
Safety
Commitment
Integrity
Passion
Our Vision & Values
At TML.science, we are committed to advancing healthcare via Faecal Microbiota Transplant (FMT). Our goal is to provide safe, effective, and scientifically backed treatments that improve patient outcomes and restore gut health, contributing to the growing field of microbiome-based treatments.
Quality
Safety
Commitment
Integrity
Passion
Our Donors
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 TML.science 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. This supports our strict quality control processes to achieve safe, high quality FMT products.
Click the following links to discover more about our screening process.
TML.science Employ Advanced Manufacturing Processes Developed from Over 15 Years’ FMT Experience to Ensure Clean and Safe FMT Products
We manufacture FMT products using fresh donations each day from our approved screened donors. Fresh stool donations are processed less than 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.
Purification
01
Unnecessary waste materials such as undigested food, dead cells, mucus, solid debris, water, salt, fibre, and fat are removed to achieve the highest level of purification possible.
Storage
02
Finished FMT products are stored in ultra-low freezers at -85°C.
Quarantine
03
Finished FMT products are quarantined for at least 90 days prior to being released, ensuring there are no slow-to-show infections in our donors.
Stool Tests
04
Our products are tested for most common pathogens in the stool via stool PCR analysis.
We also test for Covid-19 in the stool via RNA extraction and RT-PCR analysis.
Blood Tests
05
We test our donors for a variety of blood test targets to ensure product quality and safety.
Release
06
The release of FMT products is strictly governed by established Standard Operating Procedures (SOPs) to ensure patient safety and product quality. Upon completion of all required testing and quality checks, FMT products may only be released if both the donor and the donor material are found to be fully compliant with the pre-defined acceptance criteria
Only once the acceptance criteria have been fully satisfied and documentation is complete, a Qualified Person (QP) or Designated Responsible Person will perform a final review and formally authorise the release of the product.
Partner with Us to Access High Quality FMT Products for Your Patients
We provide Good Manufacturing Practices (GMP) manufactured FMT solutions, detailed product specifications, and dedicated support every step of the way. Whether you’re looking to expand your treatment options or require expert guidance, we’re here to support.
Get in Touch Today – Let’s build a trusted partnership focused on patient outcomes.