Microbiotacapsules according to 2004/23/EG

Purpose and goal: With the help of external consultants, Bactaviva will build laboratory and administrative routines adapted to the regulations of the tissue directive. The goal is to be able to offer autologous as well as donated intestinal flora (faeces) in capsules produced according to the revised tissue directive,

which is expected to be ready by April 2024, and where faeces will be included as a Substance of Human Origin (SoHO). Expected results and effects: We expect to be the first approved tissue facility for intestinal flora (feces) to offer capsules that normalize disturbed intestinal flora (microbiota dysbiosis). Capsules with donated flora to treat

antibiotic-induced diarrheal disease as well as capsules with autologous (personal) intestinal flora to prevent diarrheal disease, multiresistant bacteria and disturbed metabolism will be offered to clinics via Bactaviva´s website. This flexible and cost-effective service will lead to reduced morbidity and mortality and thus lower healthcare costs and reduce suffering.

Approach and implementation: ** Denna text är maskinöversatt ** In a project group with consultants, internal employees and healthcare representatives, we together build up routines that are adapted to both the tissue directive and production requirements as

care needs. Through practical evaluations and continuous reconciliations, we have established a robust and reproducible process that can be described and controlled according to current tissue directives. Thus, we can easily make the adaptations that may be needed to the revised tissue directive, which was approved on April 24, 2024.