Endotoxin Testing: Drugs, Medical Devices and Biopharmaceuticals
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Description
The aim of this course is to give you a full understanding of the LAL test including principles, practice, limitations and regulatory considerations. Endotoxins are recognized as being by far the most significant pyrogen, but they are often poorly understood. LAL testing for the presence of endotoxins is now a well established procedure in the manufacture of products that enter the blood stream. The course will cover the nature of endotoxins and the implications of their biochemical properties for the LAL test and cell cultures. The principles of the various LAL methodologies will be given and the advantages/ disadvantages of each will be considered. Strategies for overcoming and avoiding problems will be explained. The course will examine the FDA Guideline on LAL Testing and the USP Bacterial Endotoxins Test with a view to writing SOPs for LAL testing. The value of in-process testing will be stressed.
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