Lyophilized Biologics and Vaccines : Modality-Based Approaches.

ISBN:

9781493923830

Title:

Author:

Varshney, Dushyant.

Personal Author:

Varshney, Dushyant.

Physical Description:

1 online resource (399 pages)

Contents:

"Preface" -- "Contents" -- "Contributors" -- "Part I " -- "Lyophilization History and Fundamentals" -- "History of Lyophilization" -- "Introduction" -- "Historical Events in Development of Lyophilization" -- "Prehistoric Events" -- "Realization of Freeze-Drying Process: Early 1900s" -- "Development and Popularity of Lyophilization in Food Products" -- "Current Scope of Lyophilization" -- "History of Lyophilization of Vaccines" -- "Summary" -- "References" -- "Heterogeneity of Protein Environments in Frozen Solutions and in the Dried State" -- "Introduction" -- "Experimental Evidences of Heterogeneity of Protein Environment in Frozen Solutions and Dried Solids" -- "Mechanisms for the Inhomogeneity" -- "Protein Sorption on Interfaces" -- "Solute Inclusion Inside Ice Crystals" -- "Inhomogeneity as a General Property of Solutions and Glasses" -- "Conclusions" -- "References" -- "Advance Understanding of Buffer Behavior during Lyophilization" -- "Introductionundefined" -- "Definition, Functional Role, and Classificationundefined" -- "Characterization Methodsundefined" -- "Phosphate Bufferundefined" -- "Carboxylic Acid Buffersundefined" -- "Amines and Amino Acidsundefined" -- "Phosphate Versus Citrate Buffer: Case Studyundefined" -- "Conclusionundefined" -- "Advances in Instrumental Analysis Applied to the Development of Lyophilization Cycles" -- "Key Phase Transitions During the Lyophilization Process" -- "Coupling of Lyophilization Process and Product Attributes: Lyophilization Cycle Design" -- "Lyophilization Design Space for Primary Drying" -- "Recent Advancements in Thermal Analysis" -- "Optical Coherence Tomography-Based FDM" -- "Instrument Description" -- "Measurement Results" -- "Tunable Diode Laser Absorption Spectroscopy" -- "TDLAS Applications" -- "Conclusion" -- "References".

"New Developments in Controlled Nucleation: Commercializing VERISEQÂ® Nucleation Technology" -- "Introduction" -- "Overview of Current Technologies Offering Controlled Nucleation" -- "VERISEQÂ® Nucleation Technology: Background, Technical Approach, Scale-Up" -- "Results and Discussion" -- "Case Studies" -- "Conclusions" -- "References" -- "Part II " -- "Lyophilized Biologics and Vaccines - Modality Considerations" -- "Lyophilized Biologics" -- "Lyophilized Formulations" -- "Lyophilization Design and Stability Considerations of Various Biologics" -- "Stabilization by Lyophilization" -- "Lyophilization Cycle Development" -- "General Development Approaches" -- "Strategy for Initial Formulations" -- "Frozen Liquid Formulation" -- "Lyophilized Formulation" -- "Liquid Formulation with Limited Expiry" -- "Strategy for Commercial Formulations" -- "Frozen Formulations" -- "Liquid Formulations" -- "Lyophilized Formulations" -- "Delivery Devices" -- "Strategy to Switch Formulations" -- "Strategy for Different Modality of Biologics" -- "Formulation Role in Business Strategy" -- "Target Product Profile" -- "Market Feedback" -- "Issues Specific to Lyophilized Formulations" -- "Business Issues by Development Phase" -- "Discovery" -- "Pre-IND" -- "Early Clinical" -- "Late Clinical and Launch" -- "Post Launch: Life-Cycle Management" -- "References" -- "Lyophilization of Therapeutic Proteins in Vials: Process Scale-Up and Advances in Quality by Design" -- "Introduction" -- "Lyophilization Scale-Up" -- "Ice Nucleation Differences During Freezing" -- "Heat and Mass Transfer Differences" -- "Differences in Primary Drying Time" -- "QbD Approach" -- "QbD: Elements and Protein Modality Considerations" -- "QbD: Quality Risk Management" -- "Lyophilization in a Vial" -- "Vial Heat Transfer Coefficient, Kv" -- "Summary of Kv Values in Common Vial Types".

"Lyophilization Development and Scale-Up" -- "Liquid Characterization" -- "Freeze-Dryer Qualification (OQ/PQ)" -- "Freezing Step" -- "Ice Nucleation, Supercooling, and Annealing" -- "Nucleation Control: Principles and Methodologies" -- "Primary Drying" -- "Mass Transfer: Sublimation and Cake Resistance (â€ŠRp)" -- "Primary Drying Design Space Modeling: Designing Robustness Upfront" -- "Primary Drying End-Point Determination" -- "Secondary Drying" -- "Lyophilization Cycle Scale-Up" -- "Solid-State Characterization" -- "Case Study to Obtain Design Space" -- "Modeling of Primary Drying for a Robust Design Space" -- "Expand the Design Space Using a Scale-Down Model" -- "Establishment of a Scale-Down Model" -- "Experimental Studies for Process Characterization" -- "Summary" -- "References" -- "Advances in Process Analytical Technology in Freeze-Drying" -- "Introduction" -- "Process Analytical Technology" -- "Product Temperature Probe" -- "Wireless Product Temperature Probe" -- "Pirani Gauge Versus Barometric Endpoint Determination" -- "Manometric Temperature Measurement" -- "Tunable Diode Laser Adsorption Spectroscopy" -- "Plasma Emission Spectroscopy (LyoTrack)" -- "Near-Infrared Spectroscopy" -- "Off-Line Determination of Residual Water in Freeze-Dried Solids" -- "In-Line Process Monitoring for Protein Conformation and Proteinâ€“Excipient Interactions" -- "Raman Spectroscopy" -- "Impedance Spectroscopy" -- "Summary" -- "Conclusions and Future State" -- "References" -- "Process Scale-Up and Optimization of Lyophilized Vaccine Products" -- "Introduction" -- "Drivers for Vaccines and Lyophilization of Product" -- "Vaccine Drug Product Development Stages" -- "Introduction to Formulation Development" -- "Stage 1" -- "Preformulation" -- "Identifying an Initial Formulation for Safety Assessment and Toxicology Studies".

"Early Stage Formulation Development (Identification of Safety Assessment/Toxicology Formulation):" -- "Stage II" -- "Vaccine Drug Product Optimization (Exploration of the pH, Excipients, Stabilizers, and Process Conditions)" -- "Late-Stage Formulation/Drug Product Development" -- "Application of QbD to Vaccine Formulation Development" -- "Defining the Global Target Product Profile" -- "End-to-End Development for Vaccine Lyophilized Products" -- "Lyophilized Formulation Development" -- "Stage 1: Freezing" -- "Stage 2: Primary Drying" -- "Stage 3: Secondary Drying" -- "PAT Development" -- "Applying PAT in Drug Product Operations" -- "Scale-Up to Clinical Development/Early Launch Commercialization" -- "Environmental and Equipment Considerations" -- "Systems Considerations" -- "Case Study 1: Impact of Lyophilization Cabinet Loading Process on Product Appearance" -- "Case Study 2: Equipment and Facility Design Considerations" -- "Summary" -- "References" -- "Stabilization of Plasmid DNA and Lipid-Based Therapeutics as Dehydrated Formulations" -- "Introduction" -- "Preservation of DNA" -- "Formulation of Plasmid DNA" -- "Stability of Dried Plasmid DNA" -- "Moisture Effect on DNA Preservation" -- "Lipids" -- "Oxidation" -- "Aqueous Liposomal Formulations: Effect of Lipid Saturation" -- "Incorporation of Charged Lipids" -- "Incorporation of Antioxidants" -- "Lyophilized Lipid Formulations" -- "Hydrolysis" -- "Effect of pH" -- "Inclusion of Cationic and Anionic Lipids" -- "Nonviral Vectors as Dehydrated Medicines: Lipid/DNA Complexes" -- "Formulation of Lipid/DNA Complexes" -- "Stability of Lipid/DNA Complexes" -- "Effect of Moisture on Lipid/DNA Complex Stability" -- "Conclusions" -- "References" -- "Part III " -- "Advances in Alternate Drying" -- "Alternatives to Vial Lyophilization" -- "Introduction" -- "Sterile Spray-Drying" -- "Bulk Tank Freeze-Drying".

"Aseptic Crystallization and Drying" -- "Vacuum-Drying" -- "Drying on a Fiber Matrix" -- "Aseptic Powder Filling" -- "Aseptic Reconstitution Cartridge Hybrid" -- "Reformulation as Liquid" -- "Conclusions" -- "References" -- "Spray-Drying of Biopharmaceuticals" -- "Introductionundefined" -- "Basics of Spray-Dryingundefined" -- "Conventional Spray-Dryingundefined" -- "Alternative Spray-Drying Methodsundefined" -- "Spray-Drying Process Optimization for Biopharmaceuticalsundefined" -- "Lyophilization Versus Spray-Dryingundefined" -- "Challenges Specific to Spray-Dried Biopharmaceuticalsundefined" -- "Applications of Spray-Dried Biopharmaceuticalsundefined" -- "Spray-Dried Biopharmaceuticals for Pulmonary Deliveryundefined" -- "Spray-Drying for Vaccine Stability and Deliveryundefined" -- "Spray-Drying for the Formulation of Inhaled Insulinundefined" -- "Concluding Remarksundefined" -- "References" -- "Current Trends and Advances in Bulk Crystallization and Freeze-Drying of Biopharmaceuticals" -- "Introduction" -- "Bulk Protein Crystallization (Process Development, Advantages, and Significance in Biopharmaceutical Development Process)" -- "Bulk Freeze-Drying: Practical Considerations in Process Development and Scale-Up" -- "GOREÂ® LYOGUARDÂ® Freeze-Drying Trays: Biopharmaceutical Application" -- "Conclusion" -- "References" -- "Case Studies and Examples of Biopharmaceutical Modalities Processed by Bulk Crystallization or Bulk Freeze-Drying" -- "Introduction" -- "Insulin" -- "Aprotinin" -- "Ovalbumin" -- "Lysozyme" -- "L-Methionine Î³-Lyase " -- "Crystalline Monoclonal Antibodies " -- "Conclusions and Future Trends" -- "References" -- "Part IV " -- "Regulatory, Packaging and Technology Transfer Considerations" -- "Lyophilization of Biologics: An FDA Perspective" -- "Introductionundefined".

"General Steps for Implementing QbD in the Lyophilization of Biologicsundefined".

Local Note:

Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2018. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.

Subject Term:

Medicine.

Monoclonal antibodies.

Pharmaceutical technology.

Vaccines.

Added Author:

Singh, Manmohan.

Format:

Electronic Resources

Electronic Access:

Click here to view book

Publication Date:

2015

Publication Information:

New York, NY :

Springer,

2015.

Available:*

Shelf Number	Material Type	Copy	Shelf Location	Status
664.02845	1:E-BOOK	1	1:ON-DEMAND	Searching... Unknown

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Summary

This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused ), complex biologics (e.g., antibody drug conjugate, PEGylated proteins ), and vaccines (e.g., recombinant-protein based ). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products.

Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch:

Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer,packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch

Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.

Author Notes

Dushyant B. Varshney, Ph. D. , has made significant contributions in manufacturing science and technology, tech transfer, product and process development (including lyophilization), quality-by-design and process analytical technologies for biologics, vaccines and small molecules. Having earned his Ph.D. from the University of Iowa, Dr. Varshney has authored several peer-reviewed scientific publications, review articles, and book chapters, and has presented at several international conferences and chaired scientific workshops. He is currently a Director of Manufacturing Assessment, MS&T at Hospira, Inc. He has previously worked at Novartis, Bristol-Myers Squibb, Sanofi and Eli Lilly & Company.

Manmohan Singh, Ph.D. , is a well-known expert in the area of vaccine formulations and adjuvant research, and has been working in vaccine R&D for the last 20 years. He has authored over 130 peer reviewed manuscripts, review articles, and book chapters, and has edited five books in this area. Dr. Singh is on the editorial board of 11 International Journals and has collaborated in organizing several international vaccine conferences. Currently, he is the Head of Global Drug Product Development at Novartis Vaccines and Diagnostics in Holly Springs, NC 27540.