The Changing Landscape of Regulations

Live Biotherapeutics: European SoHO Regulations are Coming

The European regulatory landscape is evolving. The forthcoming new Substances of Human Origin (SoHO) regulation will transform the microbiome innovator’s path to treat patients and consumers. Microbiome innovators should be aware of the upcoming changes to the handling, processing, storage, and use of human microbiome samples as they’ll be included in the scope of the new European SoHO Regulation.

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As the requirements of SoHO and GMP regulations take shape for the manufacture of live biotherapeutic products, regulators are emphasising the need for standardisation, quality assurance and manufacturing controls. In the case of products containing fastidious anaerobic bacteria, one critical parameter is atmospheric control during manufacture. Precise control of anaerobiosis (exclusion of oxygen) is vital for ensuring the potency and clinical efficacy of such LBPs.

To tackle batch-to-batch variability, microbiome innovators are adopting effective strategies to ensure long-term success. Drawing on the enhanced efficacy of anaerobically prepared Faecal Microbiota Transplantation (FMT) products, the use of HEPA filtered anaerobic workstations is increasing. This approach enhances not only clinical efficacy but also sustained viability and diversity of obligate anaerobes across batches, providing a compliant platform to meet regulator's requirements for therapy approval.

This content is a collaboration between the Pharmabiotic Research Institute (PRI) and Don Whitley Scientific.

"The PRI is Europe’s Microbiome Regulatory Science Centre, and our purpose is to support and foster the development of innovative health products emerging from microbiome science, by bridging stakeholders in industry, academia, and EU regulatory representatives."

Founded in 2010, the PRI is a non-profit organisation that represents 80+ industry and academic members, in a variety of microbiome product research & development continuum.

A note from the PRI:

Make sure you are aware of the latest developments in terms of European microbiome regulatory science principles – it is critical for the success of the field and ultimately for the benefit of patients and consumers.