A small biotechnology-research company, based in the Copenhagen area of Denmark, produce FMT capsule manually to treat patients and for research purposes, seeks partner to manufacture their patented FMT capsule machine, through a supplier agreement. The manually produced FMT capsule have been used since 2020 to treat patients and for research purposes, shown 80% efficacy in patient infected with recurrent Clostridioides difficile infection. The products also showed effect in patients with Anorexia Nervosa and to eradicate antibiotic resistant bacteria in colonized patient.
The European supplier must meet a high-quality specification and strict delivery timetables. Existing customers include a large hospital in Denmark/ Hvidovre Hospital and large Hospital in Finland/ HUS Hospital in Helsinki. The quality specification requires is:
• The supplier carries sufficient stock to meet minimum order quantities of 10 units
• Delivery required throughout Europe in a maximum of 6 months.
• Equipment must come with regularly service included in the package.
• Production plants must use renewable energy, and sustainably manufactured
• Equipment must be at least partly recyclable
Advantages and innovation
FMT basically works by the fact that stool from a healthy donor changes the intestinal environment and microbiota in disease by outcompeting existing microbiota and restoring balance in the intestinal microbiota.
Technical Specification or Expertise Sought
The leaflet display equipment supplier must ;
• Be able to manufacture and been an established supplier of the equipment
• Have technical expertise to train end-users on the equipment usage
• Provide a guarantee on the equipment supplied
• Meet industry by ISO13485, ISO 9001 standards for quality
• Meet the CE marking requirements
• Have an intern regulatory framework expertise
• Provide a modular system where additional equipment updates can be easily added