| Description |
1 online resource (413 p.) |
| Contents |
Cover -- Half Title -- Title Page -- Copyright Page -- Table of Contents -- Preface -- Author Biography -- Introduction By Professor Francisco Baralle -- 1 Overview of the Development of Biosimilar Biopharmaceuticals -- 1.1 Introduction -- 1.2 Biosimilarity -- 1.3 Terminology -- 2 Regulatory Requirements for a Proposed Biosimilar Product -- 2.1 Qualification of a Product AS A Proposed Biosimilar -- 2.1.1 Qualified Reference Product -- 2.1.2 Mechanism of Action -- 2.1.3 Route of Administration -- 2.1.4 Dosage Form -- 2.1.5 Strength -- 2.1.6 Formulation -- 2.1.7 Drug Delivery Device |
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2.1.8 Current Good Manufacturing Practice Compliance -- 2.1.9 Extrapolation and Substitution -- 2.1.10 Study Waivers -- 2.1.11 Public Domain Knowledge -- 2.1.12 Reference Product -- 2.1.12.1 Reference Standard -- 2.2 Analytical Considerations -- 2.2.1 Physicochemical Properties -- 2.2.2 Nonclinical Testing -- 2.2.2.1 Immunochemical Properties -- 2.2.3 Purity and Impurity Profiles -- 2.2.4 Quantity -- 2.2.5 Specifications -- 2.2.6 Test Procedures -- 2.2.7 Function-Based Tests -- 2.2.8 Number of Batches -- 2.2.9 Data Evaluation -- 2.2.10 Expression System -- 2.2.11 Post-Translational Modifications |
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2.2.12 Quality Aspects -- 2.2.13 Release Specification -- 2.2.14 Formulation -- 2.2.15 Stability -- 2.2.16 Process Qualification -- 2.3 Animal Toxicology -- 2.4 Clinical Pharmacology -- 2.5 Clinical Immunogenicity -- 2.5.1 Pharmacodynamic Studies -- 2.5.1.1 Clinical Immunogenicity -- 2.5.2 Clinical Efficacy in Patients -- 2.5.3 Clinical Safety -- 2.6 Extrapolation -- 2.6.1 Pharmacovigilance -- 2.7 Interchangeability and Substitution -- 2.7.1 Miscellaneous -- 2.7.1.1 Naming -- 2.7.1.2 Label -- 2.7.1.3 Substitution -- 2.7.1.4 Pediatrics -- 2.7.1.5 Human Factors Studies -- 2.7.2 Risk Management |
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2.8 Documentation -- 3 Development of a Master Plan for the Biosimilar -- 3.1 Choice of The Product -- 3.1.1 Competition -- 3.1.2 Cost of Goods -- 3.1.3 Manufacturing Plan and Facility -- 3.1.4 Expression System -- 3.1.5 Batch Size -- 3.1.6 Residual Uncertainty -- 3.1.7 Clinical Safety and Efficacy -- 3.2 Historical Data On Regulatory Compliance -- 3.3 Planning for Manufacturing -- 4 Trends in the Manufacturing of Recombinant Proteins -- 4.1 Background -- 4.2 Process Optimization -- 4.2.1 Cell Line Development -- 4.2.2 Cell Culture Media -- 4.2.3 High-Cell Density Cryopreservation |
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4.2.4 Cell Culture Operations -- 4.2.5 Bioreactor Cycle -- 4.3 Single-Use Technology -- 4.3.1 Containers and Mixing Systems -- 4.3.2 Drums, Containers, and Tank Liners -- 4.3.2.1 Two-Dimensional Bags -- 4.3.2.2 Three-Dimensional Bags -- 4.3.3 Advantages of Single-Use Technology -- 4.3.4 Single-Use Bioreactors -- 4.3.5 Other Components -- 4.3.5.1 Optical Sensors -- 4.3.5.2 Biomass Sensors -- 4.3.5.3 Electrochemical Sensors -- 4.3.5.4 Pressure Sensors -- 4.3.5.5 Sampling Systems -- 4.3.5.6 Connectors -- 4.3.5.7 Tubing -- 4.3.5.8 Pumps -- 4.3.5.9 Tube Welder and Sealers -- 4.3.6 Sampling |
| Summary |
Since 1972 when recombinant engineering was invented, over 500 therapeutic proteins have been approved. Today, biological drugs constitute almost 70% of all new drugs and are of biological origin. The first edition of this book dealt with biosimilars, the second focuses on new drugs yet limits to therapeutic proteins |
| Notes |
Description based upon print version of record |
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4.3.7 Downstream Processing |
| Genre/Form |
Electronic books
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| Form |
Electronic book
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| ISBN |
9781003860235 |
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1003860230 |
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