Challenges in protein product development. ([2018])

• Record Type: Book
• Further Information: Note: Nicholas W. Warne, Hanns-Christian Mahler, editors.
• Editors: Warne, Nicholas W; Mahler, Hanns-Christian
• Contents: Intro; Preface; Contents; Contributors; Abbreviations; Formulation Development of Biologics; 1 Introduction into Formulation Development of Biologics; Abstract; 1.1 Introduction; 1.2 Formulation Development Strategies and Approaches; 1.2.1 Protein Formulation: Beyond Stabilization; 1.2.2 Components of a Protein Formulation; 1.2.2.1 Active Pharmaceutical Ingredient and Drug Substance; 1.2.2.2 Excipients; 1.2.2.3 Primary Packaging Material; 1.2.3 Preformulation; 1.2.4 Formulation Development; 1.2.4.1 Formulation Development Strategies; 1.2.4.2 Early Stage Formulation Development. 1.2.4.3 Late-Stage Formulation Development1.2.4.4 Formulation Development After Commercialization; 1.3 Challenges During Formulation Development; 1.3.1 Amount and Quality of DS; 1.3.2 Selection of Analytical Methods and Stress Conditions; 1.3.2.1 Analytical Methods; 1.3.2.2 Stability Testing and Forced-Degradation Studies; 1.3.3 Manufacturability and Formulability; 1.3.4 Data Handling and Analysis; 1.4 Conclusions; References; Further Reading; Challenges with Excipients; 2 Polysorbate Degradation and Quality; Abstract; 2.1 Introduction; 2.2 Chemical Structure, Synthesis and Composition. 2.2.1 Structure Heterogeneity in PS20 and PS802.3 Use in Biotherapeutics; 2.4 Interaction of Nonionic Surfactants with Proteins; 2.5 Interactions of Protein-Surfactant Mixtures at Interfaces; 2.6 Pharmacopoeia Requirements and Commercially Available Grades of Polysorbate; 2.7 Stability and Degradation in Formulations; 2.8 Mechanistic Pathways of Polysorbate Degradation; 2.9 Hydrolysis; References; 3 Sucrose and Trehalose in Therapeutic Protein Formulations; Abstract; 3.1 Introduction; 3.2 Physical Properties; 3.2.1 Introduction; 3.2.2 Solution-State Properties; 3.2.3 Solid-State Properties. 3.2.4 Chemical Properties3.3 Use in Formulations and Stabilization Mechanisms; 3.3.1 Liquid State; 3.3.2 Frozen State; 3.3.3 Lyophilized State; 3.4 Regulatory and Safety Aspects; 3.4.1 Regulatory Aspects; 3.4.2 Safety Aspects; 3.5 Summary and Recommendations; References; High Concentration Proteins; 4 Introduction to High-Concentration Proteins; Abstract; 4.1 Overview of Recombinant Therapeutic Proteins; 4.1.1 Antibody Therapeutics; 4.1.2 Concentration Ranges of Marketed Biotherapeutics; 4.2 Need for High-Concentration Protein Products; 4.2.1 Routes of Administration. 4.2.2 High Dose Requirement4.2.3 Long-Term Drug Administration; 4.2.4 Manufacturing Cost; 4.3 Overall Challenges in Developing High-Concentration Products; 4.3.1 Theoretical Considerations; 4.3.2 Physical Properties and Influencing Factors of High-Concentration Proteins; 4.3.2.1 Solution Viscosity; 4.3.2.2 Protein Conformation; 4.3.2.3 Aggregation Tendency; 4.3.2.4 Factors Influencing Protein-Protein Interactions; 4.3.3 Major Challenges; 4.3.3.1 Formulation Development; 4.3.3.2 Process Development; 4.3.3.3 Drug Administration; 4.4 Future Directions.
• Publisher Details: Cham, Switzerland Arlington, Va : Springer American Association of Pharmaceutical Scientists
• Publication Date: 2018
• Extent: 1 online resource
• Subjects: 615.19; Pharmaceutical biotechnology; Proteins -- Biotechnology; MEDICAL -- Pharmacology; Pharmaceutical biotechnology; Proteins -- Biotechnology; Electronic books
• Languages: English
• ISBNs: 9783319906034; 3319906038
• Related ISBNs: 9783319906010; 3319906011
• Notes: Note: Includes bibliographical references and index.; Note: Online resource; title from PDF title page (EBSCO, viewed June 25, 2018).
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.