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Bacterial Endotoxins Test (BET)Regulatory expectations and method validation
LAL and more
Bacterial endotoxins are lipopolysaccharides found in the cell membrane of Gram-negative bacteria. Their presence might cause adverse events in patients. Therefore, for all sterile parenteral drugs, medical devices and combination products, endotoxin level must be monitored and controlled throughout the manufacturing process. The most common testing method for bacterial endotoxin detection and quantitation is the in vitro Limulus Amoebocyte Lysate...Continue reading
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Issues to be covered
- Bacterial endotoxins (lipopolysaccharides) structure
- LAL reaction – from the nature to a tube
- regulatory expectations and pharmacopeial testing chapters
- LAL techniques (for bacterial endotoxin detection and quantitation):
- Gel clot
- Photometric method – Chromogenic and Turbidimetric
- Inhibition or Enhancement Test/Test for Interfering Factors, and method optimization.
- MVD (Maximum Valid Dilution) calculation
- Method verification (in-house or at external lab)
- Low endotoxin Recovery (LER)
- Alternative method (such as: Monocyte Activation Test, Recombinant Factor C Assay, Rabbit pyrogen test.
- Collaboration with external lab – Be the expert: choosing the appropriate lab, familiarization with the regulatory requirements, taking an active part in writing/reviewing verification protocols and reports, understanding the working procedure, assay troubleshooting, results interpretation
Who should attend
- Laboratory personal responsible for conducting BET
- Quality control and quality assurance personal from the biotechnology, pharmaceutical and medical device industries
- R&D personal
- Manufacturing personal
- Medical care personal (from the public institutes – such as: Dialysis units, Sterile Supply Units, Catheterization units)
Benefits to the Participants
- Limulus Amoebocyte Lysate (LAL) – available testing techniques, Advantages and Disadvantages of each technique, how to choose the appropriate testing procedure?
- LAL verification approach
- Current regulatory expectations
- Alternative testing methods
About The Lecturer
Orly Niderman-Meyer
Dr. Orly Niderman-Meyer, is the Microbiology and biochemistry department manager
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