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Rationalisation of the purification process for a phage active pharmaceutical ingredient.

B Lapras1, C Marchand2, C Merienne2

  • 1Hospices Civils de Lyon, Edouard Herriot Hospital, Pharmacy Department, FRIPHARM®, F-69437 Lyon, France; Claude Bernard Lyon 1 University, French National Centre for Scientific Research (CNRS), Institut de Biologie et de Chimie des Protéines (IBCP), Tissue Biology and Therapeutic Engineering Laboratory (LBTI), UMR 5305, F-69007 Lyon, France.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|August 7, 2024
PubMed
Summary
This summary is machine-generated.

Phage therapy is reviving due to antibiotic resistance. This review details a four-step purification process for bacteriophages (phages), addressing impurity challenges and enabling scalable production for therapeutic use.

Keywords:
BacteriophagesPhage active pharmaceutical ingredientPhage lysate impuritiesPhage purificationRationalisation of process developmentSeparation unit operations

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Area of Science:

  • Biotechnology
  • Bioprocess Engineering
  • Microbiology

Background:

  • Phage therapy, a potential alternative to antibiotics, faced challenges in purification and stability.
  • The rise of antibiotic resistance necessitates renewed interest and development in phage therapy.

Purpose of the Study:

  • To review common impurities in phage lysates.
  • To present a four-step purification process for bacteriophages.
  • To propose a framework for developing scalable and transferable phage purification processes.

Main Methods:

  • Discussion of physicochemical properties of contaminants, phage-related, and propagation-related impurities.
  • Elaboration of a four-step purification strategy: clarification, capture/concentration, purification, and polishing.
  • Development of a framework considering scalability, transferability, and duration for process design.

Main Results:

  • Identification of key impurities in phage lysates and strategies to remove them.
  • A structured four-step purification process tailored for bacteriophages.
  • A framework to guide the rational development and validation of phage purification processes.

Conclusions:

  • Advances in separation technologies enable efficient phage purification.
  • The proposed framework aids in selecting and validating unit operations for scalable phage production.
  • This work supports the resurgence of phage therapy by addressing critical manufacturing challenges.