Pyrogenicity of phage active pharmaceutical ingredients used for personalized therapy in Belgium - PubMed
7 hours ago
- #Quality Control
- #Pyrogenicity Testing
- #Phage Therapeutics
- Assessment of pyrogenicity is critical for phage-based therapeutic products, especially for intravenous administration.
- Current endotoxin tests (LAL and rFC) capture only part of immune-activating potential; the Monocyte Activation Test (MAT) offers physiological relevance by detecting responses to endotoxins and non-endotoxin pyrogens.
- The study found low pyrogenicity in tested phage active pharmaceutical ingredients (pAPIs), with most batches below 1000 EU/ml.
- A two-tiered quality control strategy is proposed: using rFC for initial endotoxin screening and MAT to assess pyrogenic potential as perceived by the human immune system.
- MAT supports interpretation of complex pyrogenic signals without overruling rFC, aligning with ethical 3Rs principles for animal use reduction.