Best Practice Manufacturing and Quality Standards for Bacteriophage Therapy Products: Australian Consensus Statements

@misc{watts2026best,
  title = {{Best Practice Manufacturing and Quality Standards for Bacteriophage Therapy Products: Australian Consensus Statements}},
  author = {K. Watts and R. C. Lin and S. Lynch and J. Warning and J. J. Barr and N. Ben Zakour and A. Campbell and J. Chan and L. Collie and M. Hedges and B. Hudson and A. Irwin and A. Khatami and A. Kicic and D. Laucirica and C. Lauter and K.-m. Ling and R. Ng and N. Pavuk and R. Rahmatullah and H. Sinclair and E. Tucker and S. Vreugde and M. Warner and Z. Velickovic and j. iredell},
  howpublished = {medRxiv},
  year = {2026},
  month = aug,
  doi = {10.64898/2026.08.26.26361487},
  url = {https://www.medrxiv.org/content/10.64898/2026.08.26.26361487v1},
  note = {CC BY-NC},
}

TY  - UNPB
TI  - Best Practice Manufacturing and Quality Standards for Bacteriophage Therapy Products: Australian Consensus Statements
AU  - K. Watts
AU  - R. C. Lin
AU  - S. Lynch
AU  - J. Warning
AU  - J. J. Barr
AU  - N. Ben Zakour
AU  - A. Campbell
AU  - J. Chan
AU  - L. Collie
AU  - M. Hedges
AU  - B. Hudson
AU  - A. Irwin
AU  - A. Khatami
AU  - A. Kicic
AU  - D. Laucirica
AU  - C. Lauter
AU  - K.-m. Ling
AU  - R. Ng
AU  - N. Pavuk
AU  - R. Rahmatullah
AU  - H. Sinclair
AU  - E. Tucker
AU  - S. Vreugde
AU  - M. Warner
AU  - Z. Velickovic
AU  - j. iredell
PY  - 2026
DA  - 2026/08/26
PB  - medRxiv
DO  - 10.64898/2026.08.26.26361487
UR  - https://www.medrxiv.org/content/10.64898/2026.08.26.26361487v1
AB  - ObjectiveAs antimicrobial resistance (AMR) continues to threaten global public health, bacteriophage therapy products (BTPs) offer a promising alternative to conventional antimicrobials.  However, translation into routine clinical practice requires best practice standards for manufacturing and quality control to ensure the consistent safety, quality, and reliability of personalised BTPs produced for individual patients or small cohorts.  DesignA modified Delphi methodology was used to develop consensus statements, engaging experts from Australias National Bacteriophage Therapy Regulatory Working Group across the fields of clinical microbiology, phage biology, good manufacturing practice (GMP), regulatory science, and government. The process comprised three iterative phases: (1) structured statement development, (2) an anonymous REDCap survey, and (3) a hybrid consensus meeting. The strength of evidence and recommendations was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework.  ResultsConsensus was reached on 35 statements to provide best practice manufacture and quality control guidance for BTPs. These statements address requirements for phage identification and characterisation; define the point at which GMP-aligned processes commence for ubiquitous phages; outline quality control expectations for phage active pharmaceutical ingredient (pAPI) production and maintenance of BTP and host cell repositories. Additional guidance covers quality management systems, including documentation, traceability, and governance.  ConclusionThese consensus statements provide comprehensive best practice recommendations for the manufacture and quality control of BTPs in Australia. By promoting consistent, safe, and quality-assured approaches to personalised BTPs, they aim to facilitate clinical implementation while remaining aligned with existing international pharmacopoeial standards and regulatory frameworks.  Significance of this studyO_ST_ABSWhat is already known on this subject?C_ST_ABSO_LIBacteriophage Therapy Products (BTPs) have re-emerged as a potential solution to antimicrobial resistance (AMR), supported by growing clinical evidence and global research activity. Data available to the regulatory working party includes more than 70 high-risk patients treated with dozens of different bacteriophages under a national open-label protocol (unpubl.). C_LIO_LIPublished guidance from the European Pharmacopoeia, European Medicines Agency (EMA), UK Medicines & Healthcare products Regulatory Agency (MHRA), and World Health Oragnization (WHO) exists, yet no practical standards for personalised BTP manufacture have been established. C_LI  What are the new findings?O_LIRecommendations have been made to define minimum quality and manufacturing stasndards for the safe, consistent production of BTPs. C_LIO_LIThis is the first expert endorsed, risk-based framework to support the translation of personliased BTPs into routine clinical practice, cobering manufacture, repository management, quality control and supply. C_LI  How might it impact on clinical practice in the foreseeable future?O_LIThese consensus statements, developed by Australias National Bacteriophage Therapy Regulatory Working Group, can assist researchers, clinicians and regulatory authorities to develop BTP production protocols. C_LI
ER  -