Biophysics for Therapeutic Protein Development (eBook)
IX, 293 Seiten
Springer New York (Verlag)
978-1-4614-4316-2 (ISBN)
This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.
This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.
Biophysics for Therapeutic Protein Development 4
Contents 6
Contributors 8
Chapter 1: Introduction 11
Chapter 2: High-Throughput Biophysical Approaches to Therapeutic Protein Development 16
Chapter 3: Techniques for Higher-Order Structure Determination 41
Chapter 4: Biophysical Techniques for Protein Size Distribution Analysis 91
Chapter 5: Qualification of Biophysical Methods for the Analysis of Protein Therapeutics 106
Chapter 6: Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and Its Application to Enhance Developability Properties 134
Chapter 7: Application of Biophysics in Formulation, Process, and Product Characterization: Selected Case Studies 154
Chapter 8: Biophysical Analysis in Support of Development of Protein Pharmaceuticals 180
Chapter 9: Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size 212
Chapter 10: Investigation of Nonconformance During Protein Therapeutic Manufacturing 251
Chapter 11: Higher-Order Structure and Protein Aggregate Characterization of Protein Therapeutics: Perspectives from Good Manufacturing Practices and Regulatory Guidance 267
Index 288
| Erscheint lt. Verlag | 26.2.2013 |
|---|---|
| Reihe/Serie | Biophysics for the Life Sciences | Biophysics for the Life Sciences |
| Zusatzinfo | IX, 293 p. 73 illus., 31 illus. in color. |
| Verlagsort | New York |
| Sprache | englisch |
| Themenwelt | Medizin / Pharmazie ► Gesundheitsfachberufe |
| Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie | |
| Medizin / Pharmazie ► Pharmazie | |
| Studium ► 1. Studienabschnitt (Vorklinik) ► Biochemie / Molekularbiologie | |
| Naturwissenschaften ► Biologie ► Biochemie | |
| Naturwissenschaften ► Physik / Astronomie ► Angewandte Physik | |
| Technik | |
| Schlagworte | biopharmaceuticals • Biophysics • biotherapeutics • Lifecycle • Protein Aggregation |
| ISBN-10 | 1-4614-4316-4 / 1461443164 |
| ISBN-13 | 978-1-4614-4316-2 / 9781461443162 |
| Haben Sie eine Frage zum Produkt? |
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