Limit search to available items
114 results found. Sorted by relevance | date | title .
Book Cover
E-book
Author Behera, Basanta Kumara

Title Biopharmaceuticals Challenges and Opportunities
Published Milton : Taylor & Francis Group, 2020

Copies

Description 1 online resource (295 p.)
Contents Cover -- Half Title -- Title Page -- Copyright Page -- Table of Contents -- Preface -- Author -- Chapter 1 Biopharmaceuticals - A New Frontier -- 1.1 Continuous Manufacturing -- 1.1.1 Fully Integrated Continuous Process -- 1.1.2 Continuous Upstream Process and Capture Followed by Batch -- 1.1.3 Batch Upstream with Continuous Downstream -- 1.2 Era of Biopharmaceuticals -- 1.3 Challenges to Personalized Medicine -- 1.3.1 Quality and Regulatory Issues -- 1.3.2 Personalized Medicine for Social Acceptability -- 1.3.3 Payers -- 1.4 Global Biopharmaceutical Industries
1.5 Biopharmaceuticals vs Pharmaceuticals -- 1.6 Biosimilars vs Biobetters -- 1.6.1 Biobetters Based on Protein Structure Engineering -- 1.7 Bioprinting -- 1.7.1 Pre-Bioprinting -- 1.7.2 Bioprinting Processing -- 1.7.3 Post-Processing -- 1.7.4 4D Bioprinting -- 1.7.5 Biomedical Applications -- 1.7.5.1 Multiple Drugs Incorporation -- 1.7.5.2 Personalized Drug Dosing -- 1.7.6 New Analytical Techniques -- 1.8 Biopharmaceuticals Market -- 1.8.1 Current Trends in Biopharmaceuticals Market -- 1.8.2 Market Dynamics -- 1.8.3 Drivers -- 1.8.4 Restraints -- 1.8.5 Opportunities -- 1.8.6 Challenges
1.9 Biopharmaceutical Companies vs Pharmaceutical Companies -- 1.10 Biopharmaceuticals Nomenclature -- 1.10.1 Permeability -- 1.10.2 Dissolution -- 1.10.3 Biowaiver -- 1.11 Cost of R&D -- References -- Chapter 2 Biopharmaceutical Production -- 2.0 Introduction -- 2.1 Fundamental Understanding of Product Development -- 2.1.1 Regulatory -- 2.1.2 Manufacturing/Quality -- 2.1.3 Preclinical Development -- 2.1.4 Clinical Development -- 2.2 Biological Manufacturing of Biopharmaceuticals -- 2.2.1 Introduction to Microbial Fermentation -- 2.2.2 Why Choose Microbial Fermentation?
2.2.3 Microbial Strain Source, Design, and Application -- 2.2.3.1 Microbial Strain Source -- 2.2.3.2 Microbial Strain Design -- 2.2.3.3 Microbe Preservation Techniques -- 2.3 Host Cells for the Production of Biopharmaceuticals -- 2.3.1 Escherichia coli -- 2.3.2 Unicellular Fungal Host Cell System -- 2.3.3 Filament Fungi -- 2.3.4 Human Cell Lines as Host System -- 2.3.5 Animal Cells as Host System -- 2.3.6 Insect Cell-Based System -- 2.4 Quality by Design -- 2.4.1 Why Is Quality by Design? -- 2.4.2 Conceptual Development Quality Management -- 2.4.3 Elements of QbD -- 2.4.4 Important of QbD
2.4.5 How Does Quality by Design Works? -- 2.4.6 Regulatory Aspects to QbD -- 2.4.6.1 FDA Perspective -- 2.4.6.2 ICH Guidelines and QbD -- 2.4.6.3 Regulatory Challenges and Inspection -- 2.5 Process Analytical Technology (PAT) -- 2.5.1 Advantages of PAT -- 2.5.2 Chemometrics -- 2.5.3 PAT Tool Boxes -- References -- Chapter 3 Transition from Pharmaceutical Plants to Biopharma Sector -- 3.1 Production of Pharmaceuticals from Microbes -- 3.1.1 Antibiotics -- 3.1.2 Therapeutic Enzymes -- 3.1.3 Glycosylated Therapeutic Proteins -- 3.1.3.1 The Biological Roles of Glycans
Notes Description based upon print version of record
Form Electronic book
ISBN 9781351013130
1351013130