ABSTRACT

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 Limulus amebocyte lysate (LAL) such as assay development, automation, depyrogenation. Completely revised and exp

chapter 1|26 pages

Historical and Emerging Themes

ByKevin L. Williams

chapter 2|20 pages

Endotoxin Relevance and Control Overview

ByKevin L. Williams

chapter 3|20 pages

Fever and the Host Response

ByKevin L. Williams

chapter 4|24 pages

Endotoxin Structure, Function, and Activity

ByKevin L. Williams

chapter 5|20 pages

Descent of Limulus: Arthropoda and the New Biology

ByKevin L. Williams

chapter 7|20 pages

Nonendotoxin Microbial Pyrogens: Lesser Endotoxins and Superantigens

ByKevin L. Williams

chapter 8|14 pages

Risk Assessment in Parenteral Manufacture

ByEdward Tidswell

chapter 9|24 pages

Endotoxin as a Standard

ByKevin L. Williams

chapter 10|30 pages

Limulus Amebocyte Lysate Discovery, Mechanism, and Application

ByKevin L. Williams

chapter 11|40 pages

Limulus Amebocyte Lysate Assay Development, Validation, and Regulation

ByKevin L. Williams

chapter 12|12 pages

The Pyrogen Test

ByKaren J. Roberts

chapter 13|12 pages

Pyrogenicity Case Studies

ByJames F. Cooper, Kevin L. Williams

chapter 15|28 pages

Depyrogenation Validation, Pyroburden, and Endotoxin Removal

ByKevin L. Williams

chapter 16|32 pages

Automation, Process Analytical Technology, and Prospective Testing

ByKevin L. Williams

chapter 17|22 pages

Limulus Amebocyte Lysate Testing of Medical Devices

ByPeter S. Lee

chapter 18|24 pages

Receptors, Mediators, and Mechanisms Involved in Bacterial Sepsis and Septic Shock

ByEdwin S. Van Amersfoort, Johan Kuiper