Bacteriophage Production Process Characterization and Optimization to Fight against Antimicrobial Resistant P. aeruginosa
Summary
Biopharmaceutical Biotechnology
Public
Laboratory of Bacteriophages and Phage Therapy, Center for Research and Innovation in Pharmaceutical Clinical Sciences (CRISP), Lausanne University Hospital (CHUV), Dr. Grégory Resch / Cell Production Center (CPC), Service of Pharmacy, Lausanne University Hospital (CHUV), Dr. Jean-François Brunet / HES-SO Valais, Prof. Dr. Wolfram Brück
Carmen Jungo Rhême
Skills directory
February 2025 - July 2025
In this project, the P. aeruginosa phage production process is characterized with a Quality by Design (QbD) approach in a well-controlled bioreactor environment for further process optimization and re-design.
In 2024, the P. aeruginosa phage production and purification process developed at the CHUVby the teams of Dr. Grégory Resch and Dr. Jean-François Brunet was successfully transferred to the Biofactory Competence Center (BCC). The use of chemically defined medium was evaluated and successfully implemented in 2024 for improved production of phages.
In this project, a Failure Modes and Effects Analysis (FMEA) risk assessment was carried out to evaluate and document the criticality of process parameters, material attributes, and the classification of in-process testing involved in the production and purification of P. aeruginosa phages. This assessment was performed by following Quality by Design (QbD) principles recommended by the International Council on Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use. This risk assessment serves as the basis for the characterization and optimization studies of the studied P. aeruginosa phage production process.
The optimization studies are based on Design of Experiment (DoE) approaches to systematically evaluate and enhance the P. aeruginosa phage production process.
One of the critical quality attributes of phage preparations is verification of genome sequences, which is carried out at the HES-SO Valais.
Formulation by lyophilization, also known as freeze-drying, is also addressed in this project for more convenient long-term storage of the final product.