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Customer testimonial: Henri-Mondor University Hospital (APHP), Créteil, France

Customer testimonial: Henri-Mondor University Hospital (APHP), Créteil, France

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My microbiologist’s expertise allows me to attest of the safety and hygiene that Interscience products provide. We are approaching maximum safety.

Dr B. Nebbad-Lechani
APHP Henri-Mondor
Créteil, FRANCE

APHP Henri Mondor - Dr B. Nebbad-Lechani

Dr B. Nebbad-Lechani, Hospital physician in Microbiology and responsible for fecal microbiota transplantation, Henri-Mondor Hospital Pharmacy Department, Créteil, France.

Henri-Mondor University Hospital is the second largest producer at the Paris Hospitals of fecal microbiota suspensions in syringe or capsule form for fecal microbiota transplantation (FMT). This activity ensures the dispensing of preparations to all the hospitals of the Henri-Mondor University Hospital as well as to hospitals in the Eastern Paris region.

Location: Créteil, FRANCE

Work with: DiluFlow Pro, BagFilter, BagMixer 400 S, easySpiral Dilute

Manufacturing syringes and capsules for fecal microbiota transplantation (FMT) with Interscience devices

➔ Work under a laminar flow hood

➔ No cross-contamination

➔ Optimal preservation of anaerobic conditions

Fecal microbiota transplantation (FMT) consists of administering a preparation of fecal matter from a healthy subject to a patient suffering from a pathology linked to an alteration of the intestinal microbiota, in order to exert therapeutic effects. Its efficacy is recognized in the treatment of recurrent Clostridioides difficile infections. At GHU Henri-Mondor, Dr Nebbad and her team use Interscience products to ensure the safety and hygiene of the fecal microbiota suspension manufacturing in the form of syringes or capsules.

What is the microbiota?

A microbiota is the collection of microorganisms - bacteria, viruses, parasites and non-pathogenic fungi, known as commensals - that live in a specific environment.

In the body, there are different microbiota: in the skin, mouth, vagina, lungs... The intestinal microbiota is the most "populated" of them, hosting 10¹² to 10¹⁴ microorganisms.

Microbiota and health

The role of the intestinal microbiota on our health is more and more known and recognized. We now know that it plays a role in digestive, metabolic, immune and neurological functions. Consequently, dysbiosis, i.e. qualitative and/or functional alteration of the intestinal microbiota, is a serious lead to explain certain diseases, especially those underlying autoimmune or inflammatory mechanisms.

Dr Nebbad and her team use Interscience products to produce fecal microbiota suspensions in syringe or capsule form for fecal microbiota transplantation (FMT) as part of routine treatment of recurrent Clostridioides difficile infections, with a success rate of up to 80%.

How can you go from a stool to a drug?

It all starts with the donation of stool from a healthy individual whose selection corresponds to specific criteria aimed at excluding the transmission of infectious agents as much as possible. Today, there are very few donors because few people are aware of stool donation, and the selected donor must be eligible for donation according to the recommendations of the ANSM.

Preparation of fecal
microbiota transplants

The stool is first weighed and diluted with the gravimetric dilutor DiluFlow directly into a BagFilter sampling bag, then homogenized in the paddle blender BagMixer. The lateral filter integrated to BagFilter allows to filter directly the stool during the homogenization step, so that cellular debris and non-digested food fibers are eliminated.

The recovered filtrates are kept in 10% Glycerol for the syringe form or 80% Glycerol solution for the capsule form after centrifugation.

Bacterial qualification of the preparations

The bacterial count of the preparations is performed by the Spiral counting technique (an ISO7218 standardized technique). From a stool suspension with NaCl and glycerol, the easySpiral Dilute device automatically performs serial 1/10 dilutions until a 10^-5 solution is obtained. Then, from this suspension, the automat proceeds to a plating by Spiral technique (allowing to obtain 4 logs of dilution on the same Petri dish) on different specific media for the enumeration. Each plating medium is performed in duplicate to ensure reproducibility.

“The donor is very crucial.„ Dr Nebbad

Interview with Dr B. Nebbad-Lechani, Hospital physician in Microbiology and responsible for fecal microbiota transplantation, Henri-Mondor Hospital Pharmacy Department:

Why did you need these automats?

“ We needed to save time and reduce the risk of cross-contamination.„

“ My microbiologist’s expertise allows me to attest of the safety and hygiene that Interscience products provide. We are approaching maximum safety.„

How have our devices changed your way of working?

“Interscience products are a clear improvement compared to the old preparation methods. For example, the homogenization of samples was done with a blender that had to be cleaned after each manipulation, which was a major source of cross-contamination. Today, each sample is diluted in its irradiated BagFilter using the DiluFlow and automatically homogenized by a BagMixer. The devices are not in direct contact with the sample and are compact enough to be used under a laminar flow hood or under a safety cabinet, which makes the donation as safe as possible and protects the manipulator. Moreover, with BagFilter, there is no need to filter the samples by hand, we take the filtrate directly in the bag. This reduces manipulation steps and the number of consumables in contact with the sample.

It is therefore faster and safer from a hygiene and safety point of view. As for bacterial enumeration, it is facilitated by the use of the easySpiral which allows to have directly interpretable Petri dishes thanks to its 9 dilution logs. This saves us time and allows us to have more reliable and reproducible results thanks to our double validation.„

“ Before, the homogenization of samples was done in a blender that we had to clean after each manipulation and this was a major source of cross-contamination.„ Dr Nebbad

What do you like most about our equipments?

“Interscience products give us great satisfaction for the bacterial qualification of our preparations because we work in duplicate and these devices have very reproducible performances. Moreover, the use of bags with BagClip closure sticks allows us to maintain good anaerobic conditions, essential for the culture of bacteria living in the intestine. The compact format of Interscience devices allows their use under a laminar flow hood or a safety cabinet and reduces the risks of contamination. „

If you had to define Interscience products in 3 words:

“Safe, easy to use and robust.„

PROTOCOL OF ANALYSIS

Bacterial quantification of donor stool and FMT preparations

• Number of analysis per day: depends on the rate of donations
• Dilution mode: Automatic mode with the DiluFlow
• Dilution factor: 1:4 (v/v)
• Microorganisms: Cultivable facultative aero-anaerobic flora of the intestinal microbiota
• Culture medium: TSA, Drigalski, Schaedler KV 5% of sheep’s blood, Bifidobacterium, LBS, Colombia 5% horse blood
• Colony Counting: Manual

Testimonial (PDF - 377 kb)