Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes 1st Edition Gunter Jagschies

Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes 1st Edition Gunter Jagschies – Ebook Instant Download/Delivery ISBN(s): 9780081006238,0081006233, 9780128125526, 0128125527

Product details:

• ISBN 10: 0128125527
• ISBN 13: 9780128125526
• Author: Gunter Jagschies

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.

Table contents:

Chapter 1: Disease and Healthcare Priorities

Chapter 2: Brief Review of the Biopharmaceutical and Vaccine Industry

Chapter 3: Selected Biotherapeutics Overview

Chapter 4: Process Capability Requirements

Chapter 5: Upstream Bioprocessing: Basic Concepts

Chapter 6: Host Cells

Chapter 7: Cell Line Development

Chapter 8: Cell Culture Media in Bioprocessing

Chapter 9: Industry Review of Cell Separation and Product Harvesting Methods

Chapter 10: Overview of Alternative Separation Methods in Relation to Process Challenges

Chapter 11: Alternative Separation Methods: Flocculation and Precipitation

Chapter 12: Alternative Separation Methods: Crystallization and Aqueous Polymer Two-Phase Extraction

Chapter 13: Expanded Bed Adsorption

Chapter 14: Filtration Principles

Chapter 15: Filtration Methods for Use in Recovery Processes

Chapter 16: Introduction to Preparative Protein Chromatography

Chapter 17: Affinity Chromatography

Chapter 18: Ion Exchange Chromatography

Chapter 19: Hydrophobic Interaction Chromatography

Chapter 20: Multimodal Chromatography

Chapter 21: Size Exclusion Chromatography (SEC)

Chapter 22: Reversed Phase Chromatography

Chapter 23: Filtration Methods for Use in Purification Processes (Concentration and Buffer Exchange)

Chapter 24: Upstream Processing Equipment

Chapter 25: Downstream Processing Equipment

Chapter 26: Chromatography Columns

Chapter 27: Simplification of Buffer Formulation and Improvement of Buffer Control with In-Line Conditioning (IC)

Chapter 28: Continuous Capture of mAbs—Points to Consider and Case Studies

Chapter 29: Single Use Technology and Equipment

Chapter 30: Process Control and Automation Solutions

Chapter 31: The Upstream Process: Principal Modes of Operation

Chapter 32: Downstream Process Design, Scale-Up Principles, and Process Modeling

Chapter 33: Cleaning-in-Place and Sanitization

Chapter 34: The Search for Process Intensification and Simplification: Alternative Approaches versus Current Platform Processes for Monoclonal Antibodies

Chapter 35: Single-Use Technology Implementation For Biologics and Vaccines Production

Chapter 36: Points to Consider for Design and Control of Continuous Bioprocessing

Chapter 37: Perfusion N-1 Culture—Opportunities for Process Intensification

Chapter 38: Process Development and Intensification for a Recombinant Protein Expressed in E.coli

Chapter 39: Next-Generation Process Design for Monoclonal Antibody Purification

Chapter 40: Process Development and Manufacturing of Antibody-Drug Conjugates

Chapter 41: Process Design for Bispecific Antibodies

Chapter 42: Current Manufacturing of Human Plasma Immunoglobulin G

Chapter 43: Modern Production Strategies in the Vaccine Industry

Chapter 44: Bioprocesses for Cell Therapies

Chapter 45: Facility Design and Process Utilities

Chapter 46: Points to Consider in Manufacturing Operations

Chapter 47: Analytical Methods

Chapter 48: Implementation of QbD for Manufacturing of Biologics—Has It Met the Expectations?

Chapter 49: Pathogen Safety

Chapter 50: Chemistry, Manufacture and Control

Chapter 51: Post-Licensure Purification Process Improvements for Therapeutic Antibodies: Current and Future States

Chapter 52: Navigating the Regulatory Maze Upon Process Changes

Chapter 53: Security of Bioprocess Consumables Supply

Chapter 54: Basics of Financial Management

Chapter 55: Management of Process Economy—Case Studies

Chapter 56: Appendix 1—The Ideal-World Research Portfolio

Chapter 57: Appendix 2—History of Biomedical Research

Chapter 58: Appendix 3—Marketed Biotherapeutics

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