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Bacteriophage Production in Compliance with Regulatory Requirements

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Bacteriophage Therapy

Part of the book series: Methods in Molecular Biology ((MIMB,volume 2734))

Abstract

In this chapter, we discuss production requirements for therapeutic bacteriophage preparations. We review the current regulatory expectancies and focus on pragmatic production processes, implementing relevant controls to ensure the quality, safety, and efficacy of the final products. The information disclosed in this chapter can also serve as a basis for discussions with competent authorities regarding the implementation of expedited bacteriophage product development and licensing pathways, taking into account some peculiarities of bacteriophages (as compared to conventional medicines), such as their specificity for, and co-evolution with, their bacterial hosts. To maximize the potential of bacteriophages as natural controllers of bacterial populations, the implemented regulatory frameworks and manufacturing processes should not only cater to defined bacteriophage products. But, they should also facilitate personalized approaches in which bacteriophages are selected ad hoc and even trained to target the patient’s infecting bacterial strain(s), whether or not in combination with other antimicrobials such as antibiotics.

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Authors and Affiliations

  1. Laboratory for Molecular and Cellular Technology, Queen Astrid Military Hospital, Brussels, Belgium

    Jean-Paul Pirnay, Maia Merabishvili, Daniel De Vos & Gilbert Verbeken

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  1. Jean-Paul Pirnay
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  2. Maia Merabishvili
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  3. Daniel De Vos
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  4. Gilbert Verbeken
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Correspondence to Jean-Paul Pirnay .

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Editors and Affiliations

  1. Centre of Biological Engineering, University of Minho, Braga, Portugal

    Joana Azeredo

  2. International Iberian Nanotechnology Laboratory, Braga, Portugal

    Sanna Sillankorva

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Pirnay, JP., Merabishvili, M., De Vos, D., Verbeken, G. (2024). Bacteriophage Production in Compliance with Regulatory Requirements. In: Azeredo, J., Sillankorva, S. (eds) Bacteriophage Therapy. Methods in Molecular Biology, vol 2734. Humana, New York, NY. https://doi.org/10.1007/978-1-0716-3523-0_6

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  • DOI: https://doi.org/10.1007/978-1-0716-3523-0_6

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  • Publisher Name: Humana, New York, NY

  • Print ISBN: 978-1-0716-3522-3

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