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
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