Fees: Member Fee £70 Join Now, £100 (Non Member)Wednesday 24th January 2024 2pm – 3pm (BST) – Includes a 10min Q&A Session
This webinar is led by: Callum Dew – Scientist, Microbiology, AstraZeneca
The presentation will cover:
Endotoxin masking in complex modalities
- Endotoxins, cell wall components of gram-negative bacteria, can represent a problematic contaminant in parenteral formulations
- Certain modalities prove to be more problematic than others with regard to establishing a valid endotoxin test
- Endotoxin testing must be performed as per pharmacopeia requirement
- PDA Technical Report 82 outlines the phenomenon of LER – Low Endotoxin Recovery
- LER studies are a requirement of BLA – Biological Licensing Applications
- The story so far – troubleshooting endotoxin masking. Describe recent results and observations in complex modalities
- Describe future troubleshooting plan
