Intestinal microbiome medicinal products
The evolution of Intestinal Microbiome Medicinal Products
This evidence base underpinning the efficacy and safety of FMT has created a rapidly growing clinical and patient demand for the treatment. However, historically, adoption of procedure has been critically limited because of the costs and logistics associated with finding donors and processing faecal donations. Furthermore, there are currently no approved pharmaceutical grade medicinal products that doctors can use as part of the procedure, which means that the material administered is less standardised than a conventional medicinal product.
These unmet needs and opportunities have spurred efforts to develop and advance a new generation of standardised microbial therapeutics, termed intestinal microbiome medicinal products (IMMPs) for use in microbiome restoration. IMMPs are standardised donor-derived microbial formulations that are manufactured using controlled starting material with validated and reproducible processes and released according to the principles of Good Manufacturing Practice (GMP) under a license from a competent authority. IMMPs can only be released for clinical use once the product is deemed to have met specific release criteria through validated analytical methods. These are key differences between an IMMP prepared industrially by a method involving a standardised and reproducible industrial process and material prepared for contemporary FMT.
EnteroBiotix is part of the ‘Intestinal Microbiome-based Medicines European Task Group (IMM-ETG)’, which aims to propose a harmonised, pan-European, regulatory approach to IMMPs, as well as facilitate communication with key stakeholders, including policy makers, regulatory agencies, academic groups, clinicians and microbiome therapeutic companies.