Del 0 - Pharmaceutical Biotechnology

Rational Design of Stable Protein Formulations

Theory and Practice

Inbunden, Engelska, 2002

AvJohn F. Carpenter,Mark C. Manning,John F. Carpenter,Mark C. Manning

2 119 kr

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Recombinant proteins and polypeptides continue to be the most important class of biotechnology-derived agents in today's pharmaceutical industry. Our fundamental understanding of how proteins degrade and how stabilizing agents work has made it possible to approach the formulation of protein pharmaceuticals from a much more rational point of view. This book describes the current level of understanding of protein instability and the strategies for stabilizing proteins under a variety of stressful conditions.

Produktinformation

Utgivningsdatum2002-04-30
Mått155 x 235 x 17 mm
Vikt512 g
FormatInbunden
SpråkEngelska
SeriePharmaceutical Biotechnology
Antal sidor206
Upplaga2002
FörlagSpringer Science+Business Media
ISBN9780306467417

Tillhör följande kategorier

Apotek och farmaceuter inom Medicin
Biokemisk teknik inom Naturvetenskap och teknik
Tillverkningsteknik inom Naturvetenskap och teknik
Biokemi inom Naturvetenskap och teknik
Farmakologi inom Medicin

1 Practical Approaches to Protein Formulation Development.- Preparation for Formulation Development.- Preformulation Development.- Formulation Development.- Formulation in Commercial Product Development.- Appendix: List of Regulatory Documents.- References.- 2 Recombinant Production of Native Proteins fromEscherichia coli.- Distribution of Expressed Proteins.- Cell Washing and Lysis.- Purification of Soluble, Folded Proteins.- Purification and Refolding of Soluble, Misfolded Proteins.- Purification and Refolding of Proteins from Inclusion Bodies.- Refolding Mechanism.- Methods to Analyze Folded Structures.- References.- 3 Physical Stabilization of Proteins in Aqueous Solution.- Overview of Physical Stability.- Interactions of Excipients with Proteins.- Physical Factors Affecting Protein Stability.- Conclusions.- Appendix: Derivation of the Wyman Linkage Function and Application to the Timasheff Preferential Exclusion Mechanism.- References.- 4 Effects of Conformation on the Chemical Stability of Pharmaceutically Relevant Polypeptides.- Relationship Between Structure and Deamidation Rates.- Role of Structure in Protein Oxidation.- Summary.- References.- 5 Rational Design of Stable Lyophilized Protein Formulations: Theory and Practice.- Minimal Criteria for a Successful Lyophilized Formulation.- Rational Design of Stable Lyophiilized Formulations.- Acknowledgments.- References.- 6 Spray-Drying of Proteins.- Introduction: Why Spray-Dry a Protein?.- Developments in the Last 10 Years.- The Practice of Spray-Drying Proteins.- Concluding Remarks.- References.- Chapter7 Surfactant-Protein Interactions.- Proteins and Surfactants at Surfaces.- Protein-Surfactant Interactions in Solution.- Surfactant Effects on Protein Assembly State.- Surfactant Effects on Proteins During Freezing, Freeze-Drying and Reconstitution.- Enzymatic Degradation of Non-Ionic Surfactants.- Recommendations for Protein Formulation.- References.- 8 High Throughput Formulation: Strategies for Rapid Development of Stahle Protein Products.- Overall Structure of the HTF Approach.- Role of an Established Decision Tree for Formulation Design.- Use of Software and Databases to Assist in the HTF Process.- Essential Analytical Methods.- Stability Protocols.- Unified Strategy for HTF.- References.