Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems / edited by Kevin L. Williams.

Format:

Book

Contributor:

Williams, Kevin L., editor.

SpringerLink (Online service)

Series:

Biomedical and Life Sciences (Springer-11642)

Language:

English

Subjects (All):

Pharmaceutical technology.

Medical microbiology.

Pharmaceutical Sciences/Technology.

Medical Microbiology.

Local Subjects:

Pharmaceutical Sciences/Technology.

Medical Microbiology.

Physical Description:

1 online resource (XI, 869 pages) : 427 illustrations, 349 illustrations in color

Edition:

First edition 2019.

Contained In:

Springer eBooks

Place of Publication:

Cham : Springer International Publishing : Imprint: Springer, 2019.

System Details:

text file PDF

Summary:

Endotoxin detection and control is a dynamic area of applied science that touches a vast number of complex subjects. The intersection of test activities includes the use of an ancient blood system from an odd "living fossil" (Limulus). It is used to detect remnants of the most primitive and destructive forms of life (prokaryotes) as contaminants of complex modern systems (mammalian and Pharma). Recent challenges in the field include those associated with the application of traditional methods to new types of molecules and manufacturing processes. The advent of "at will" production of biologics in lieu of harvesting animal proteins has revolutionized the treatment of disease. While the fruits of the biotechnology revolution are widely acknowledged, the realization of the differences in the means of production and changes in the manner of control of potential impurities and contaminants in regard to the new versus the old are less widely appreciated. Endotoxin as an ancient, dynamic interface between lifeforms, provides a singular perspective from which to view the parallel development of ancient and modern organisms as well as the progress of man in deciphering the complexity of their interactions in his efforts to overcome disease.

Contents:

Introduction

Section I Pharma

Historical Perspectives

Risk, Control and Compliance.

Sterility and Beyond

LVPs and SMDs

Specification Determination

Static and Dynamic Models (Biodiversity and Heterogeneity)

Test Development and Validation

Diminishing Analytics

Control in Biologics Manufacture

Depyrogenation and Medical Devices

Nanoparticles / Problematic Drug Types

New Frontiers

Section II Limulus

Evolution, a Living Fossil and Other Model Arthropods

Water, Water Everywhere

Survival and Mass Extinction Events

Limulus Soup / Hemolymph

Is Innate Modeling Enough?

A Foreboding

Section III Mammalian

Innate is Inborn

The Host Response: Fever and Inflammation

. Parallel Immune Systems: Architecture and Mechanisms

Structural Change is Functional Change (Hand in Glove)

Endotoxin and Adjuvanticity in Vaccinology

Advances in Diagnostics

The Big S.

Other Format:

Printed edition:

ISBN:

978-3-030-17148-3

9783030171483

Access Restriction:

Restricted for use by site license.