Endotoxins: Pyrogens, LAL Testing and Depyrogenation

by Williams; Kevin

• ISBN13: 9780849393723
• ISBN10: 0849393728
• Edition: 3rd
• Format: Hardcover
• Copyright: 2007-02-23
• Publisher: CRC Press

Summary

This source expertly 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 Limulusamebocyte lysate (LAL) such as assay development, automation, depyrogenation.  Completely revised and expanded, this Third Editioncontains 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.

Table of Contents

Historical and emerging themes	p. 1
Endotoxin relevance and control overview	p. 27
Fever and the host response	p. 47
Endotoxin structure, function, and activity	p. 67
Descent of Limulus : arthropoda and the new biology	p. 91
Microbial biodiversity and lipopolysaccharide heterogeneity : from static to dynamic models	p. 111
Nonendotoxin microbial pyrogens : lesser endotoxins and superantigens	p. 133
Risk assessment in parenteral manufacture	p. 153
Endotoxin as a standard	p. 167
Limulus amebocyte lysate discovery, mechanism, and application	p. 191
Limulus amebocyte lysate assay development, validation, and regulation	p. 221
The pyrogen test	p. 261
Pyrogenicity case studies	p. 273
Developing specifications for active pharmaceutical ingredients, excipients, raw materials, sterile pharmacy compounds, and nutritional supplements	p. 285
Depyrogenation validation, pyroburden, and endotoxin removal	p. 301
Automation, process analytical technology, and prospective testing	p. 329
Limulus amebocyte lysate testing of medical devices	p. 361
Receptors, mediators, and mechanisms involved in bacterial sepsis and septic shock	p. 383
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