Optimizing the Production of Therapeutic Bacteriophages Through Quality by Design: A Case Study on Pseudomonas Aeruginosa.

A Failure Modes and Effects Analysis (FMEA) risk assessment was conducted to evaluate and document the criticality of process parameters and material attributes involved in a Pseudomonas aeruginosa phage production process. This assessment was carried out following the principles of Quality by Design (QbD) as outlined by the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use. By systematically identifying and controlling critical factors, this approach contributes to the development of a more robust and reproducible phage production process, ultimately enhancing process efficiency and product quality.