Lyophilized Biologics and Vaccines: Modality-Based Approaches - Softcover

Softcover

ISBN 10: 1493955683 ISBN 13: 9781493955688

Publisher: Springer, 2016

Synopsis

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.

About this title

About the Author

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.

From the Back Cover

This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch lyophilized biologics or vaccine products, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fusion), complex biologics (e.g., antibody drug conjugates, PEGylated proteins) and vaccines (e.g., recombinant protein based). The authors adeptly guide you through everything you need to know, from biophysical and chemical stability considerations of proteins, to critical assessment during process scale-up, technology transfer, packaging, alternate drying and device selection for a successful process validation, regulatory submission and launch of a stable, safe and effective product.

Lyophilized Biologics and Vaccines: Modality-Based Approaches 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 in frozen systems, buffer stabilization, instrumental analysis and controlled ice nucleation technology
• Details product development strategies based on diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics
• Recent updates on quality-by-design and process analytical technology approaches, illustrated by case studies and FDA perspective
• Provides the latest account of alternate drying technologies including spray drying and bulk freeze-drying

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 productdevelopment and commercial manufacturing.

Dushyant B. Varshney, Ph.D., has made significant contributions in manufacturing science and technology, due diligence, tech transfer, product and process development (including lyophilization), quality-by-design and process analytical technologies for biologics, vaccines and small molecules. He is currently a Director of Manufacturing Assessment, MS&T at Hospira Inc.

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 is currently the Head of Global Drug Product Development at Novartis Vaccines and Diagnostics in Holly Springs, NC.

Edition details

• Publisher: Springer
• Publication date: 2016
• Language: English
• ISBN 10: 1493955683
• ISBN 13: 9781493955688
• Binding: Paperback
• Number of pages: 412
• Editor: Varshney Dushyant, Singh Manmohan