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Development of live biotherapeutic products: a position statement of Asia-Pacific Microbiota Consortium

Tseng CH 1 , Wong S 2 , Yu J 3 , Lee YY 4 , Terauchi J 5 , Lai HC 6 Show all authors , Luo JC 7 , Kao CY 8 , Yu SL 9 , Liou JM 10 , Wu DC 11 , Hou MC 7 , Wu MS 10 , Wu JJ 12 , Sung JJY 13 , El-Omar EM 14 , Wu CY 15

Affiliations 

  • 1 Germark Biotechnology, Co, Ltd, Taichung, Taiwan
  • 2 Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore
  • 3 Department of Medicine and Therapeutics, Institute of Digestive Disease, and The State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, SAR, China
  • 4 School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Kelantan, Malaysia
  • 5 Japan Microbiome Consortium (JMBC), Osaka, Japan
  • 6 Department of Medical Biotechnology and Laboratory Science, College of Medicine, Chang Gung University, Kwei-Shan, Taiwan
  • 7 Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
  • 8 Institute of Microbiology and Immunology, National Yang Ming Chiao Tung University, Taipei, Taiwan
  • 9 Department of Clinical Laboratory Sciences and Medical Biotechnology, College of Medicine, National Taiwan University, Taipei, Taiwan
  • 10 Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
  • 11 Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
  • 12 Department of Medical Laboratory Science and Biotechnology, Asia University, Taichung, Taiwan
  • 13 Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore dr.wu.taiwan@gmail.com e.el-omar@unsw.edu.au josephsung@ntu.edu.sg
  • 14 UNSW Microbiome Research Centre, University of New South Wales, Sydney, New South Wales, Australia dr.wu.taiwan@gmail.com e.el-omar@unsw.edu.au josephsung@ntu.edu.sg
  • 15 Microbiota Research Center, Health Innovation Center, and Institute of Biomedical Informatics, National Yang Ming Chiao Tung University, Taipei, Taiwan dr.wu.taiwan@gmail.com e.el-omar@unsw.edu.au josephsung@ntu.edu.sg
Gut, 2025 Feb 26.
PMID: 40011030 DOI: 10.1136/gutjnl-2024-334501

Abstract

OBJECTIVE: Live biotherapeutic products (LBPs) are biological products composed of living micro-organisms, developed to prevent, treat, or cure diseases. Examples include cultured strains of Akkermansia muciniphila and Christensenella minuta, as well as treatments using purified Firmicutes spores for recurrent Clostridioides difficile infections. There is a need for guidelines over the increasing interest in developing LBPs. A panel of microbiome experts from Asia-Pacific countries articulates their perspectives on key considerations for LBP development.

DESIGN: Experts in microbiome research, microbiology, gastroenterology, internal medicine and biotherapeutics industry were invited to form a panel. During the 2023 Inauguration Conference of the Asia-Pacific Microbiota Consortium, an organised, iterative roundtable discussion was conducted to build expert consensus on critical issues surrounding the development of LBP.

RESULTS: The consensus statements were organised into three main aspects: (a) rationales of LBP development, (b) preclinical studies and (c) preparation for clinical studies. The panel strongly recommended to prioritise human-derived and food-sourced strains for development, with indications based on clinical need and efficacy shown in studies. Preclinical evaluation should involve thorough screening, genotyping and phenotyping, as well as comprehensive in vitro and animal studies to assess functional mechanisms and microbiological safety. Rigorous cell banking practices and genetic monitoring are essential to ensure product consistency and safety throughout the manufacturing process. Clinical trials, including postmarketing surveillance, must be carefully designed and closely monitored, with robust safety and risk management protocols in place.

CONCLUSIONS: The development of LBP should be approached with a strong emphasis on microbiological evaluation, clinical relevance, scientific mechanisms and safety at every stage. These measures are essential to ensure the safety, effectiveness and long-term success of the product.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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