This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers.

Updates include:

sources and productivity

types of products made today

experiences in clinical and licensed products

economics

current status of validation

illustrations and tables

automated column packing

automated systems

New topics include:

the use of disposables

multiproduct versus dedicated production

design principles for chromatography media and filters

ultrafiltration principles and optimization

risk assessments

characterization studies

design space

platform technologies

process analytical technologies (PATs)

biogenerics

comparability assessments

Key Features:

new approaches to process optimiaztion

use of patform technologies

applying risk assessment to process design