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Advanced Manufacturing, Formulation and Microencapsulation of Therapeutic Phages.

Danish J Malik1, Henrique Goncalves-Ribeiro1, Dirk GoldSchmitt2,3

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Summary

Manufacturing bacteriophage drug products requires robust process control and monitoring. Optimizing critical parameters ensures stable, high-quality products for effective phage therapy.

Keywords:
phage deliveryphage therapyupstream and downstream processing

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Area of Science:

  • Biotechnology
  • Pharmaceutical Manufacturing
  • Drug Development

Background:

  • Manufacturing stable, high-dose bacteriophage drug products (DPs) for clinical use necessitates improved process monitoring and control.
  • Ensuring product quality requires mapping critical process parameters (CPP) to critical quality attributes (CQA) for both upstream (USP) and downstream processes (DSP).

Purpose of the Study:

  • To highlight the importance of process analytical technologies (PAT) for enhanced monitoring and control in bacteriophage manufacturing.
  • To emphasize the need for early-stage formulation considerations in pre-clinical development of bacteriophage DPs.

Main Methods:

  • Discussion of single-use technologies as a preferred manufacturing option for phage bioprocess development and drug substance (DS) manufacture.
  • Integration of process analytical technologies (PAT) for improved process robustness and productivity, leading to high phage titers.

Main Results:

  • Implementation of PAT can reduce batch-to-batch variability and increase productivity in phage manufacturing.
  • Precise formulation of bacteriophage DPs in various dosage forms can significantly enhance phage therapy outcomes.

Conclusions:

  • Early consideration of formulation, including physiochemical properties, excipient compatibility, and storage stability, is crucial for bacteriophage DP development.
  • Scalable manufacturing, cost-effectiveness, and regulatory compliance are key factors for successful bacteriophage drug product development and clinical application.