Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

This series provides engineers with vapor pressure data for process design, production, and environmental applications.

Organic compounds --- Vapor pressure --- Compounds, Organic --- Organic chemicals --- Carbon compounds --- Pressure --- Sublimation (Chemistry)

Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

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 product development 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.

Biomedicine. --- Vaccine. --- Antibodies. --- Pharmaceutical Sciences/Technology. --- Medicine. --- Monoclonal antibodies. --- Vaccines. --- Pharmaceutical technology. --- Médecine --- Anticorps monoclonaux --- Vaccins --- Techniques pharmaceutiques --- Biology --- Health & Biological Sciences --- Microbiology & Immunology --- Pharmacy, Therapeutics, & Pharmacology --- Freeze-drying. --- Frozen drugs. --- Cryopharmacy --- Drugs --- Drugs, Frozen --- Freezing of drugs --- Lyophilization --- Freezing --- Cryobiology --- Drying apparatus --- Refrigeration and refrigerating machinery --- Sublimation (Chemistry) --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Technology --- Antibodies, Monoclonal --- Monoclonal immunoglobulins --- Immunoglobulins --- Molecular cloning --- Biologicals --- Antibodies --- Immune globulins --- Immune serum globulin --- Blood proteins --- Globulins --- Plasma cells --- Antibody diversity --- Antigens --- Bacterial immunoglobulin-binding proteins

Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

Cryopreservation and Freeze-Drying Protocols: Second Edition is a compilation of robust, reproducible techniques for the conservation of a wide range of biological materials. This widely expanded second edition includes novel approaches and protocols for biological materials that were not preservable when the first edition was published in 1995. This volume begins with a discussion of long term ex situ conservation of biological resources, the role of biological resource centers, and fundamental principles of freeze-drying and cryopreservation. Each chapter focuses on the preservation of specific biological materials, including proteins, mircroorganisms, cell lines, and multicellular structures. Detailed descriptions of materials required and stepwise protocols are presented for each preservation method, along with explanatory notes that highlight key technical issues. The troubleshooting and background notes provided for each protocol enhance this practical and reliable resource for the conservation and sustainable use of biological resources.

Cryopreservation of organs, tissues, etc. --- Freeze-drying --- Lyophilization --- Cryoconservation of organs, tissues, etc. --- Cryogenic preservation of organs, tissues, etc. --- Low temperature preservation of organs, tissues, etc. --- Methodology. --- Life sciences. --- Biochemistry. --- Cell biology. --- Plant physiology. --- Animal physiology. --- Biophysics. --- Biological physics. --- Biomaterials. --- Life Sciences. --- Biochemistry, general. --- Cell Biology. --- Biophysics and Biological Physics. --- Animal Physiology. --- Plant Physiology. --- Cryobiology --- Drying apparatus --- Refrigeration and refrigerating machinery --- Sublimation (Chemistry) --- Preservation of organs, tissues, etc. --- Cryonics --- Cytology. --- Biological and Medical Physics, Biophysics. --- Botany --- Plants --- Physiology --- Animal physiology --- Animals --- Biology --- Anatomy --- Biocompatible materials --- Biomaterials --- Medical materials --- Medicine --- Biomedical engineering --- Materials --- Biocompatibility --- Prosthesis --- Cell biology --- Cellular biology --- Cells --- Cytologists --- Biological chemistry --- Chemical composition of organisms --- Organisms --- Physiological chemistry --- Chemistry --- Medical sciences --- Composition --- Bioartificial materials --- Hemocompatible materials --- Biomaterials (Biomedical materials)