Therapeutic Protein Drug Products
Practical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic
Description
Key Features
- Provides a list and description of commercially available therapeutic drug products and their formulations
- A comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinic
- Discusses recent topics including high protein concentration, phase separation, opalescence, and subvisible particles
Readership
Table of Contents
List of figures and tables
Preface
About the authors
Chapter 1: Commercial therapeutic protein drug products
Abstract
1.1 Introduction
1.2 Lyophilized formulations
1.3 Liquid formulations
1.4 Protein formulations for radiologic and diagnostic use
1.5 Summary
Chapter 2: A formulation method to improve the physical stability of macromolecular-based drug products
Abstract
2.1 Introduction
2.2 Common techniques used for the construction of EPDs
2.3 The peptide drug pramlintide
2.4 Monoclonal antibodies at low and high concentration
2.5 Static vs. dynamic EPDs: a case study using a humanized immunoglobulin (IgG1)
2.6 Conclusion and future studies
Chapter 3: Properties of protein formulations
Abstract
3.1 Introduction
3.2 Opalescence
3.3 Phase separation
3.4 Color
3.5 Subvisible particles
Chapter 4: Material and process compatibility testing
Abstract
4.1 Introduction
4.2 Material compatibility
4.3 Process compatibility testing
4.4 Antimicrobial preservative compatibility testing
Chapter 5: Compounding and filling: drug substance to drug product
Abstract
5.1 Introduction
5.2 Aseptic processing
5.3 Bulk drug substance
5.4 Compounding of drug product
5.5 Filling the drug product
Chapter 6: Administration in the clinic
Abstract
6.1 Introduction and background
6.2 Diluents
6.3 Components
6.4 Construction materials
6.5 Clinical dosing strategy: fixed volume versus fixed concentration
6.6 Representative admixture concentration levels
6.7 Exposure temperature and time
6.8 Option of using syringes
6.9 Analytical tests and acceptance criteria
6.10 Sample preparation considerations
6.11 Role of probe studies
6.12 Bag overfill volume
6.13 Pharmacy instructions
6.14 Conclusions
Chapter 7: Regulatory guidelines for the development of a biotechnology drug product
Abstract
7.1 Introduction
7.2 ICH overview
7.3 Common Technical Document (CTD)
7.4 Drug product dossier
7.5 Regulatory considerations through the biotechnology product lifecycle
7.6 Conclusions
Appendix
Recommended reading
Index
Product details
- No. of pages: 200
- Language: English
- Copyright: © Woodhead Publishing 2012
- Published: January 2, 2012
- Imprint: Woodhead Publishing
- Hardcover ISBN: 9781907568183
- eBook ISBN: 9781908818102
About the Editor
Brian Meyer
Affiliations and Expertise
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