Development and Manufacture of Protein Pharmaceuticals

Inbunden, Engelska, 2002

Del i serien Pharmaceutical Biotechnology

2 262 kr

Beställningsvara. Skickas inom 10-15 vardagar. Fri frakt över 249 kr.

Beskrivning

This text focuses on development, manufacture, and commercialization of pharmaceutical protein dosage forms. It envelops and emphasizes GMP attributes of quality, safety, purity, and strength. Each author provides practical, proven approaches and methods to achieve quality protein dosage forms on a commercial scale. It delves deep into practical detail on the requirements, and how to meet them, for developing, manufacturing, and gaining regulatory approval of protein dosage forms.

Produktinformation

Utgivningsdatum:2002-06-30
Mått:155 x 235 x 31 mm
Vikt:859 g
Format:Inbunden
Språk:Engelska
Serie:Pharmaceutical Biotechnology
Antal sidor:464
Upplaga:2002
Förlag:Springer Science+Business Media
ISBN:9780306467455

Utforska kategorier

Farmakologi inom Medicin
Tillverkningsteknik inom Naturvetenskap och teknik

Innehållsförteckning

1 Preformulation Studies as an Essential Guide to Formulation Development and Manufacture of Protein Pharmaceuticals.- 1. Introduction.- 2. Protein Structural Characterization and Conformational Stability.- 3. Protein Size, Quaternary Structure, Aggregation State, and Solubility.- 4. Degradative Covalent Reactions and Their Effect on Physicochemical and Biological Properties of Proteins.- 5. Conclusions.- References.- 2 Formulation Development of Protein Dosage Forms.- 1. Introduction.- 2. Why Proteins Present Unique Challenges to the Development Scientist.- 3. General Formulation Principles for Proteins.- 4. Why Packaging, Processing, and Formulation Are Interrelated.- 5. Commercially Available Protein Dosage Forms.- 6. Chemical Stabilization.- 7. Physical Stabilization.- 8. Formulation Approaches for Solving Physical Stability Problems.- 9. Additives for Antimicrobial Preservation.- 10. Other Additives.- 11. Packaging.- 12. Interface between Formulation Development and Manufacturing.- 13. Quality Considerations during Formulation Development.- 14. Examples of Formulation Problems.- References.- 3 Aseptic Processing of Protein Pharmaceuticals.- 1. Introduction.- 2. Aseptic Processing of Solution, Lyophilized, and Suspension Dosage Forms.- 3. Unique Challenges in the Aseptic Processing of Protein Pharmaceuticals.- 4. Developing Aseptic Processes for Drug Product Manufacturing.- 5. Conceptual Framework for Drug Product Process Validation.- References.- 4 Fundamentals of Thermal Sterilization Processes.- 1. Introduction.- 2. Effects of Heat on Living Cells.- 3. Factors Affecting Resistance of Microorganisms to Thermal Inactivation.- 4. Thermal Inactivation of Microorganisms.- 5. Sterility Assurance.- 6. Thermal Inactivation Kinetics.- 7. Sterilization Cycle Development.-8. Sterilization Engineering.- 9. Parametric Release of Terminally Sterilized Drug Products.- 10. Summary.- References.- 5 Membrane Filtration.- 1. Introduction.- 2. Overview of Filtration Membranes.- 3. Membrane Filtration Theory.- 4. The Practice of Sterile Filtration.- Appendix: Definition of Terms.- References.- 6 Fundamentals of Freeze-Drying.- 1. Introduction.- 2. Overview of the Freeze-Drying Process.- 3. The Freezing Process.- 4. Material Characterization.- 5. The Drying Process.- 6. Stability of Freeze-Dried Formulations.- 7. Summary.- References.- 7 Quality Assurance and Quality Control for Biopharmaceutical Products.- 1. Introduction.- 2. Defining Quality Assurance and Quality Control in Biopharmaceutical Companies.- 3. Involvement of Quality in Biopharmaceutical Manufacturing Control.- 4. Overall Quality Control Strategy for Biopharmaceutical Products.- 5. Closing Comments on Quality in Biopharmaceutical Companies.- References.- 8 Regulatory Considerations in the Development of Protein Pharmaceuticals.- 1. Introduction.- 2. Biotechnology Product Development.- 3. Production Variables.- 4. Manufacturing Process Issues.- 5. Product Quality Attributes.- 6. Evolution of the New Regulatory Paradigm.- 7. Conclusion.- References.

Mer från samma författare

Del 14

Development and Manufacture of Protein Pharmaceuticals

Steve L. Nail, Michael J. Akers

Häftad, 2012

2 262 kr

Development and Manufacture of Protein Pharmaceuticals

Michael J. Akers, Steve L. Nail

E-bok

2012

2 948 kr

Mer från samma serie

Protein Pharmacokinetics and Metabolism

Bobbe L. Ferraiolo, Marjorie A. Mohler, Carol A. Gloff

Inbunden, 1992

1 698 kr

Stability of Protein Pharmaceuticals

Tim J. Ahern, Mark C. Manning

Inbunden, 1992

2 262 kr

Stability and Characterization of Protein and Peptide Drugs

Rodney Pearlman, Y. John Wang

Inbunden, 1993

2 262 kr

Biological Barriers to Protein Delivery

Kenneth L. Audus, Kenneth L. Andus, Thomas J. Raub

Inbunden, 1993

909 kr

Vaccine Design

Michael F. Powell, Michael F. Powell, Mark J. Newman

Inbunden

909 kr

Physical Methods to Characterize Pharmaceutical Proteins

James N. Herron, James Ed. Herron, James N. Herron, Wim Jiskoot, Daan J.A. Crommelin

Inbunden, 1995

1 649 kr

Models for Assessing Drug Absorption and Metabolism

Ronald T. Borchardt, Philip L. Smith, Glynn Wilson

Inbunden, 1996

2 262 kr

Del 9

Formulation, Characterization, and Stability of Protein Drugs

Rodney Pearlman, Y. John Wang

Inbunden, 1996

2 262 kr

Protein Delivery

Lynda M. Sanders, R. Wayne Hendren

Inbunden, 1997

2 262 kr

Integration of Pharmaceutical Discovery and Development

Ronald T. Borchardt, Roger M. Freidinger, Tomi K. Sawyer, Philip L. Smith

Inbunden, 1998

2 197 kr

Du kanske också är intresserad av

10% rabatt på allt

Adventskalender Ravensburger pussel 2026

Ravensburger

319 kr

Del 14

Development and Manufacture of Protein Pharmaceuticals

Steve L. Nail, Michael J. Akers

Häftad, 2012

2 262 kr

Development and Manufacture of Protein Pharmaceuticals

Michael J. Akers, Steve L. Nail

E-bok

2012

2 948 kr

Daily Reflections and Meditations

Ryan M. Akers, Michael J. Akers

E-bok

2017

52 kr

Sterile Drug Products

Michael J. Akers

Häftad, 2024

722 kr

Sterile Drug Products

Michael J. Akers

E-bok

2016

847 kr

The Book of Genesis: A Layman's Practical Expository

Michael J. Akers

Häftad, 2020

191 kr

Book of Genesis

Michael J Akers

E-bok

2020

64 kr

Book of Genesis

Michael J Akers

Inbunden, 2020

224 kr

Morning and Evening Meditations from the Word of God

Michael J Akers

Häftad, 2014

624 kr

Development and Manufacture of Protein Pharmaceuticals

AvSteve L. Nail,Michael J. Akers

Inbunden, Engelska, 2002

Del i serien Pharmaceutical Biotechnology

2 262 kr

Beställningsvara. Skickas inom 10-15 vardagar. Fri frakt över 249 kr.

Beskrivning

Produktinformation

Utgivningsdatum:2002-06-30
Mått:155 x 235 x 31 mm
Vikt:859 g
Format:Inbunden
Språk:Engelska
Serie:Pharmaceutical Biotechnology
Antal sidor:464
Upplaga:2002
Förlag:Springer Science+Business Media
ISBN:9780306467455

Utforska kategorier

Farmakologi inom Medicin
Tillverkningsteknik inom Naturvetenskap och teknik

Innehållsförteckning

1 Preformulation Studies as an Essential Guide to Formulation Development and Manufacture of Protein Pharmaceuticals.- 1. Introduction.- 2. Protein Structural Characterization and Conformational Stability.- 3. Protein Size, Quaternary Structure, Aggregation State, and Solubility.- 4. Degradative Covalent Reactions and Their Effect on Physicochemical and Biological Properties of Proteins.- 5. Conclusions.- References.- 2 Formulation Development of Protein Dosage Forms.- 1. Introduction.- 2. Why Proteins Present Unique Challenges to the Development Scientist.- 3. General Formulation Principles for Proteins.- 4. Why Packaging, Processing, and Formulation Are Interrelated.- 5. Commercially Available Protein Dosage Forms.- 6. Chemical Stabilization.- 7. Physical Stabilization.- 8. Formulation Approaches for Solving Physical Stability Problems.- 9. Additives for Antimicrobial Preservation.- 10. Other Additives.- 11. Packaging.- 12. Interface between Formulation Development and Manufacturing.- 13. Quality Considerations during Formulation Development.- 14. Examples of Formulation Problems.- References.- 3 Aseptic Processing of Protein Pharmaceuticals.- 1. Introduction.- 2. Aseptic Processing of Solution, Lyophilized, and Suspension Dosage Forms.- 3. Unique Challenges in the Aseptic Processing of Protein Pharmaceuticals.- 4. Developing Aseptic Processes for Drug Product Manufacturing.- 5. Conceptual Framework for Drug Product Process Validation.- References.- 4 Fundamentals of Thermal Sterilization Processes.- 1. Introduction.- 2. Effects of Heat on Living Cells.- 3. Factors Affecting Resistance of Microorganisms to Thermal Inactivation.- 4. Thermal Inactivation of Microorganisms.- 5. Sterility Assurance.- 6. Thermal Inactivation Kinetics.- 7. Sterilization Cycle Development.-8. Sterilization Engineering.- 9. Parametric Release of Terminally Sterilized Drug Products.- 10. Summary.- References.- 5 Membrane Filtration.- 1. Introduction.- 2. Overview of Filtration Membranes.- 3. Membrane Filtration Theory.- 4. The Practice of Sterile Filtration.- Appendix: Definition of Terms.- References.- 6 Fundamentals of Freeze-Drying.- 1. Introduction.- 2. Overview of the Freeze-Drying Process.- 3. The Freezing Process.- 4. Material Characterization.- 5. The Drying Process.- 6. Stability of Freeze-Dried Formulations.- 7. Summary.- References.- 7 Quality Assurance and Quality Control for Biopharmaceutical Products.- 1. Introduction.- 2. Defining Quality Assurance and Quality Control in Biopharmaceutical Companies.- 3. Involvement of Quality in Biopharmaceutical Manufacturing Control.- 4. Overall Quality Control Strategy for Biopharmaceutical Products.- 5. Closing Comments on Quality in Biopharmaceutical Companies.- References.- 8 Regulatory Considerations in the Development of Protein Pharmaceuticals.- 1. Introduction.- 2. Biotechnology Product Development.- 3. Production Variables.- 4. Manufacturing Process Issues.- 5. Product Quality Attributes.- 6. Evolution of the New Regulatory Paradigm.- 7. Conclusion.- References.