We produce FMT preparations in accordance with all the recommendations that have appeared so far. Even more, we have added our know-how and personalized protocols to make the production safer and to produce FMT characterized by high cellularity and viability of bacterial cells. We run a bank of gut microbiota donors. Our donors are selected in a very restrictive, three-step procedure.
The percentage of positive qualifications to become a donor among people who contacted us and at least completed the health questionnaire is below 0.4%. We have not encountered more restrictive criteria worldwide. Each donor is tested many times, and each donor material undergoes very rigorous daily testing. We have successfully implemented our own production technology of preparations, thanks to which we obtain at least 40-60% viability of bacterial cells in the FMT assessed using the LIVE/DEAD immunofluorescence method, and the cellularity in the entire preparation, regardless of the form, is 1012-1013. So, almost as many bacterial cells as can be found in a man’s large intestine (1014) are present in our FMT preparations.
We produce two types of FMT preparations:
donor-derived high-richness, high-diversity, high-viability fecal microbiota suspension for administration via intraduodenal/intragastric/intrajejunal tubes, gastroscope, colonoscope, PEG, rectal enema. Ready-to-use kit with intestinal microbiota suspension that can be used in any form.
MBiotix HBI Caps
donor-derived high-richness, high-diversity, high-viability capsules in a double shell (acid-resistant and enteric), released at the ileocecal area, to be taken orally.
FMT preparations in capsules are best tolerated by patients. A meta-analysis of studies on the effectiveness of FMT indicates that the capsules are as effective as FMT performed by colonoscopy.
The amount of material is the same as in the case of FMT done by the classical method.
The effectiveness of C. difficile infections (CDI) treatment using our FMT preparations confirms up to 96% of complete cures (when preparations are used at least twice and 86% with a single use of our FMT preparations), regardless of the form of administration (suspension or capsules).
Each FMT is manufactured using the principle of “sample tracking”. We give each sample and each FMT preparation unique codes, thanks to which we are able to trace the entire history of the preparation and indicate which patient has received which preparation. In addition, the implemented quality assurance system makes treatment with our FMT preparations highly safe and of the highest effectiveness described in the literature.
During production, we provide proper safety and quality conditions. Fresh material must meet the required criteria and be delivered to the laboratory at the appropriate time and temperature. The production of preparations takes place under anaerobic conditions, our laboratory operates in accordance with the highest standards related to Good Manufacturing Practice (GMP). We conduct detailed molecular, microbiological, cytometric and other tests to characterize our products as well as to confirm their quality.
Donors have been subjected to detailed examinations, interviews, multi-stage qualification and are tested in each donation cycle at least twice. Every donor has a panel of over 70 tests performed on a regular basis, and each material is subjected to additional quality control tests. The products are released after the grace period, only in the case of correct donor’s results and preparation tests. Detailed information can be found in the Mbiotix HBI / Mbiotix HBI Caps quality certificate.
Storage and administration:
- Products can be stored at -80°C for up to 2 years.
- At the temperature of -20°C, products can be stored for no longer than 3 months
The suspension in the syringe kit Mbiotix HBI must be defrosted before administration. Defrosting should begin 4-6 hours before the planned procedure. Mbiotix HBI Caps is a preparation intended for oral administration. Defrosted product is not suitable for refrosting.
MBiotix HBI Caps should be given to the patient immediately after removing from the freezer. Defrosted product is not suitable for administration or refrosting.
If a patient in your facility requires Fecal Microbiota Transplant due to Clostridioides difficile infection or in any other indication upon your Bioethical Committee acceptance, do not hesitate to contact us. Every public hospital and facility may order our preparations and treat their patients. Additionally, we collaborate with many private centers (see below), including Microbiota Centers recommended by the Human Biome Institute, which are strictly applying our recommendations for patient management and following our training on the latest knowledge about microbiota.
At the Human Biome Institute, we want to support doctors in the use of fecal microbiota transplantation by providing a safe, validated medicinal preparation and knowledge how to use it. We want to help develop treatment based on the latest world discoveries.