Containing a wealth of important information for the pharmaceutical manufacturing industry, the brand new edition of this handbook:

• describes the history of fever response and LAL and puts it into context with the development and regulation of parenteral dosage forms
• examines the shift from pyrogen to endotoxin testing and the development, refinement, and computer validation of semiautomated kinetic LAL assays
• explains the importance and relevance of Limulus to the medical community and provides
• details on Toll-like receptor activation via endotoxin as a pathogen-associated molecular pattern (PAMP)
• offers a chapter on the clinical advances in understanding gram-negative sepsis
• provides new information regarding risk assessment and contamination control, as well as methods and case studies of testing liposomes, proteins, and other difficult compounds
• includes case studies discussing pyrogenic reactions to contaminated medicines

Endotoxins: Pyrogens, LAL Testing, and Depyrogenation 3rd Edition examines the discovery, biological structure, control, and continued clarification of endotoxin from a parenteral manufacturing perspective, with in-depth discussion of state-of-the-art technologies involving Limulus amebocyte lysate (LAL) such as assay development, automation, depyrogenation.

Completely revised and expanded, this Third Edition contains the knowledge necessary to apply endotoxin testing in the increasingly complex pharmaceutical environment, featuring sections detailing the latest information regarding clinical advances, regulation standards, and validation procedures for computerized kinetic tests.

Contents

1. Background
2. Historical and Emerging Themes in Parenteral Manufacturing Contamination Control
3. Endotoxin Relevance and Control Overview
4. Fever and the Host Response
5. Endotoxin Structure, Function and Activity
6. Descent of Limulus
7. Microbial Biodiversity and LPS Heterogeneity
8. Nonendotoxin Microbial Pyrogens: Lesser Endotoxins, Superantigens and Adventitious Agents
9. Parenteral Drug Testing
10. Risk Assessment in Parenteral Manufacturing
11. Endotoxin as a Standard. LAL Discovery, Mechanism and Application
12. LAL Assay Development, Validation and Regulation
13. The Pyrogen Test
14. Pyrogenicity Case Studies
15. Developing Specifications for API, Excipients and Sterile Pharmacy Compounds
16. Depyrogenation Validation, Pyroburden, and Endotoxin Removal
17. Automation, PAT and Prospective Tests
18. Medical Devices
19. LAL Testing of Medical Devices
20. Clinical
21. Receptors, Mediators, and Mechanisms Involved in Bacterial Sepsis and Septic Shock

Index

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