Studiebog
    Biopharmaceutical Processing

    Biopharmaceutical Processing

    - Development, Design, and Implementation of Manufacturing Processes

    Forfatter: info mangler
    Bog
    • Format
    • Bog, hardback
    • Engelsk

    Beskrivelse

    Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry.

    Læs hele beskrivelsen
    Detaljer
    • SprogEngelsk
    • Sidetal1308
    • Udgivelsesdato12-12-2017
    • ISBN139780081006238
    • Forlag Elsevier / The Lancet
    • FormatHardback
    Størrelse og vægt
  • Vægt2980 g
    • coffee cup img
    10 cm
    book img
    19,1 cm
    23,5 cm

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    Diabetes Performance Insulin DNA IMAC Crystallization. Electrophoresis Filtration Landscape Mass spectrometry Recombinant proteins Scalability Escherichia coli Pharmacokinetics Macular Degeneration Fermentation Organic solvents Affinity chromatography Cell culture Control Chromatography Monoclonal antibodies Purification Extraction Flocculation Apoptosis Communicable diseases Fouling Polymers Antibodies Planning Ion exchange chromatography Antibody-drug conjugates Dextran Dissolved oxygen OPTIMIZATION Risk mitigation Formulation Viral vaccines Hygienic aspects Mesenchymal stem cells Retention Plasma dø Food and Drug Administration Net present value Perfusion Design considerations Cell Therapies Product Quality SFM Facility Design Ind Good Manufacturing Practices Reorientation Bioprocessing Mammalian cell lines Business Continuity Planning Nanobodies Mass Balance GLP Size-exclusion chromatography Gene delivery HCV Bioreactor technology Impurities Gradient Hydrophobic Quality-by-design Process Economics Biomanufacturing Cmc GMP Robustness Buffers Scale-up Polymer Parameter Resins Novartis H1N1 Harvest ECM Quality by Design (QbD) Balance sheet Downstream Processing Immunogenicity Process Development Ich Glycosylated proteins Biopharmaceutical Chinese Hamster Ovary Biotherapeutics Intracellular transport HCP Process design Safety Stock Productivity Rpc -cho Partition Chimeric antigen receptor MAB Bioprocess Microfiltration CMO Heuristics Bioreactor Precipitation QBD HMI Footprint Controllers Deoxyribonucleic acid Building management system FMD COGS CFF PCV Income statement Gap-Analysis Cell viability A/E/C Column Cost of goods sold Critical quality attributes Buffer Cho Clarification Biopharma Alternative separation Batch culture Biospecifics Bispecifics CHO harvest processes Drug product Hydrophobic interaction chromatography Immunoglobulin G Polynucleotides Poverty scenario Acoustic wave separation ADC process Age standardized death rate Anion exchanger Antibody functionalization animal cells Assembly process Application areas capital expenditure Cell Concentration Cell substrates Chaotrope concentration Biosafety applications Antibody intermediate Cell Bank CIP/SIP Bioprocessing equipment Crude Death Rate Binding buffer Chromatography system CQAs Downstream systems Bulk drug substance Cell culture media Caprylate fractionation consumables Entropy-driven Ethanol fractionation CFOA Chemical compatibility exception handling Critical Process Parameters Critical quality attribute culture types EBA adsorbents Chromatography bed Drug-to-antibody ratio Column volume Clean in place Gel filtration GMP systems and documentation Filter sizing Contract manufacturing organizations HIC resins FGF21 Hydrodynamic shear Guanidine hydrochloride HETP Intramuscular injection Knob-hole bispecifics Laboratory systems Insulins Limiting dilution Feed concentration molecular composition Master production records Lab scale ­experiments Meningococcal New molecular entities Glycine-HCl Periodic counter-current chromatography HCCF Pilot-scale equipment PLC components Nonpolar ligands Novel chemical entities Novel vaccines PD workflow Prosperity scenario Process performance qualification PLC/SCADA Process analytical technology (PAT) Product lifecycle Resin blending Security of supply (SoS) Purification and separation purification process sanitization Revenue trends Sorption Kinetics IGIV kSep Systems Lifecycle l-Glutamine pH buffers MabSelect SuRe Protein A Post-licensure changes Microfiltration TFF RTD test N-1 perfusion Perfusion Culture Plasma Master File Nucleic acid vaccines Selectivity curve Retention factor Process-contacting components Production scale Scale down model

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