Lyophilized Biologics and Vaccines

Modality-Based Approaches

Dushyant Varshney, Manmohan Singh (Herausgeber)

Buch | Softcover

401 Seiten

2016 | Softcover reprint of the original 1st ed. 2015
Springer-Verlag New York Inc.
978-1-4939-5568-8 (ISBN)

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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.

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.

Preface.- Part I – Lyophilization History and Fundamentals.- History of Lyophilization.- Heterogeneity of protein environments in frozen solutions and in the dried state.- Advance understanding of buffer behavior during lyophilization.- Advances in Instrumental Analysis Applied to the Development of Lyophilization Cycles.- New Developments in Controlled Nucleation: Commercializing VERISEQ® Nucleation technology.- Part II – Lyophilized Biologics and Vaccines – Modality Considerations.- Lyophilized Biologics.- Lyophilization of Therapeutic Proteins in Vials - Process Scale-up and Advances in Quality by Design.- Advances in Process Analytical Technology in Freeze Drying.- Process Scale-up and Optimization of Lyophilized Vaccine Products.- Stabilization of Plasmid DNA and Lipid-based Therapeutics as Dehydrated Formulations.- Part III – Advances in Alternate Drying.- Alternatives to Vial Lyophilization.- Spray Drying of Biopharmaceuticals.- Current Trends and Advances in Bulk Crystallization and Freeze Drying of Biopharmaceuticals.- Case Studies and Examples of Biopharmaceutical Modalities.- Processed by Bulk Crystallization or Bulk Freeze Drying.- Part IV– Regulatory, Packaging and Technology Transfer Considerations.- Lyophilization of Biologics - An FDA Perspective.- Recent Trends in Lyophilized Delivery Devices and Packaging.- Lyophilization Technology Transfer towards Product Launch.

Erscheinungsdatum	31.10.2016
Zusatzinfo	68 Illustrations, color; 31 Illustrations, black and white; XI, 401 p. 99 illus., 68 illus. in color.
Verlagsort	New York
Sprache	englisch
Maße	155 x 235 mm
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Medizin / Pharmazie ► Pharmazie
	Studium ► Querschnittsbereiche ► Infektiologie / Immunologie
	Naturwissenschaften ► Biologie ► Biochemie
	Naturwissenschaften ► Chemie ► Technische Chemie
	Technik
Schlagworte	Biologics • Biosimilars • Lyophilization • modality • Vaccinology
ISBN-10	1-4939-5568-3 / 1493955683
ISBN-13	978-1-4939-5568-8 / 9781493955688
Zustand	Neuware