Development of live biotherapeutic products: a position statement of Asia-Pacific Microbiota Consortium
BMJ GUT 26 January 2025
A panel of microbiome experts from the Asia-Pacific region, including the MRC’s Director Professor Emad El-Omar, have released comprehensive guidelines for developing live biotherapeutic products (LBPs).
These innovative treatments, composed of living microorganisms, are designed to prevent, treat, or cure diseases. The guidelines emphasise the importance of using human-derived and food-sourced strains due to their inherent safety and effectiveness.
Key recommendations include thorough preclinical evaluations involving strain screening, genotyping, and phenotyping. In vitro and animal studies are essential to assess the safety and efficacy of LBPs before they reach human trials.
The guidelines also stress the need for rigorous cell banking practices and genetic monitoring to ensure product consistency and safety throughout manufacturing.
Clinical trials must be meticulously designed with robust safety and risk management protocols. Post-marketing surveillance is crucial to monitoring the long-term safety and effectiveness of LBPs in real-world settings. Adherence to Good Manufacturing Practices (GMP) and regulatory guidelines is vital to maintain high standards.
Professor El-Omar tells us “This paper, published in Gut, provides robust and sound guidelines for the development and use of Live Biotherapeutic Products. This is essential for achieving the optimal therapeutic benefit of these products. The Asia Pacific Microbiota Consortium is very proud to provide this important guidance”.
These guidelines aim to ensure that LBPs are developed strongly, emphasising scientific mechanisms, clinical relevance, and safety, ultimately benefiting public health.
The panel’s recommendations provide a valuable roadmap for researchers and developers in the rapidly growing field of microbiome-based therapies.
The work was first published in BMJ GUT on 26 January 2025 and can be accessed here doi:10.1136/ gutjnl-2024-334501
“This paper, published in Gut, provides robust and sound guidelines for the development and use of Live Biotherapeutic Products. This is essential for achieving the optimal therapeutic benefit of these products. The Asia Pacific Microbiota Consortium is very proud to provide this important guidance”.
Prof. Emad El-Omar
Director MRC