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 designThese assays are a measure of correct tertiary structure and should also be stability-indicating (see Section 5.2.5). ... The ICH guideline on analysis of expression construct provides details of the methods used for assessing genetic stabilityanbsp;...
|Title||:||Handbook of Process Chromatography|
|Author||:||Günter Jagschies, Gail K. Sofer, Lars Hagel|
|Publisher||:||Academic Press - 2007-12-08|