Handbook of Process Chromatography: Development, Manufacturing, Validation and Economics

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 production setups, pressure monitor, matography resin, other adsorptive modes, batch cycling, eluent velocity, zone broadening, chromatography medium, product titers, washout function, biopharma companies, dynamic binding capacity, viral clearance studies, batch frequency, nucleic acid products, ionic capacity, virus filtration, target solute, cleaning validation, membrane adsorbers, multiproduct facilities, buffer costs, chromatographic resin, rapid microbiological methods, eddy dispersion