The International Organization for Standardization (ISO) has officially released the first international standard for therapeutic bacteriophage preparation, titled “ISO/TS 20853:2026 Biotechnology — Bioprocessing — General requirements for bacteriophage preparation for therapeutic use.” This groundbreaking standard was spearheaded by BGI-Research in collaboration with the China National Research Institute of Food & Fermentation Industries Co., Ltd., China Jiliang University, Beijing University of Chemical Technology, and other leading organizations. It represents a major advancement in the global effort to standardize bacteriophage therapy preparation processes.
The International Organization for Standardization (ISO) officially released ISO/TS 20853:2026
The standard defines the minimum requirements for preparing therapeutic bacteriophage preparations and outlines best practices for critical steps, including bacteriophage isolation, purification, characterization, screening, and preservation. It also provides detailed protocols for titre detection and quality control, offering professionals a practical and comprehensive guideline to ensure consistency and quality in therapeutic bacteriophage production.
The development of ISO/TS 20853:2026 was the result of more than two years of collaboration. Since the project’s proposal to ISO in October 2023, BGI-Research has worked closely with a network of research and technical institutions to finalize the standard. By addressing long-standing gaps in the regulatory framework, this standard provides a unified foundation for advancing bacteriophage therapy, helping to ensure its sustainable development and application worldwide.
BGI-Research has been at the forefront of bacteriophage research since 2017. The organization has leveraged its strengths in high-throughput sequencing, bioengineering, and automation to develop a comprehensive innovation ecosystem that bridges basic research, applied science, and technology translation.
To support the advancement of bacteriophage technology, BGI-Research has established an integrated platform that combines a physical biobank with related database. This platform is powered by high-throughput, automated screening and functional characterization systems, which have been successfully applied in real-world clinical research and public health settings.
BGI-Research’s contributions extend beyond technological innovation. The institute has played a key role in shaping global regulatory frameworks for bacteriophage applications. Additionally, BGI-Research has contributed to key initiatives and protocols on bacteriophage applications in China.
The publication of ISO/TS 20853:2026 marks a critical milestone for the global adoption of standardized bacteriophage therapy. By providing an internationally recognized technical framework, the standard paves the way for more consistent, effective, and safe applications of bacteriophage therapies in clinical and public health contexts.
The ISO/TS 20853:2026 standard can be accessed here: