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Brian K Meyer

Therapeutic Protein Drug Products

Name: Therapeutic Protein Drug Products
Author: Brian K Meyer

Practical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic

Gebonden Engels 2012 9781907568183

179,80

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Samenvatting

Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed.

Specificaties

ISBN13:9781907568183

Taal:Engels

Bindwijze:Gebonden

Uitgever:Elsevier Science

Serie:Woodhead Publishing Series in Biomedicine

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Inhoudsopgave

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

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