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Biological Drug Products
Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their abili...
Applications of Ion Chromatography for Pharmaceutical and Biological Products
This is a comprehensive source of information on the application of ion chromatography (IC) in the analysis of pharmaceutical drugs and biologicals. This book, with contributors from academia, pharma, the biotech industry, and instrument manufacturing, presents the different perspectives, experience, and expertise of the thought leaders of IC in a comprehensive manner. It explores potential IC applications in different aspects of product development and quality control testing. In addition, an appendix section gives information on critical physical and chromatographic parameters related to IC and information on current manufacturers of IC systems, columns, and other components.
Bee Products - Chemical and Biological Properties
This book presents an updated discussion of the chemical composition and biological properties of the main bee products. Specific attention is focused on the beneficial biological activities of bee products in human health. Honey, royal jelly, propolis, bee pollen and bee venom are used as nutriment and in traditional medicine. Their composition is rather variable and depends on the floral source and external factors, such as seasonal, environmental conditions and processing. Bee products are rich in several essential nutrients and non essential nutrients, as sugars, minerals, proteins, free amino acids, vitamins, enzymes and polyphenols, that seem to be closely related to their biological functions. The effects of these products in nutrition, aging and age-related diseases, cancer, neurodegenerative diseases and pathogen infections are discussed.
Aqueous Two-Phase Systems for Bioprocess Development for the Recovery of Biological Products
This comprehensive and unique text presents a full overview of downstream processing useful for those new to the concept as well as professionals with experience in the area. The history and theoretical principles of Aqueous Two-Phase Systems (ATPS) are covered in depth. Information on ATPS characterization and application is included, and ATPS equilibria and system parameters that have significant effect on partition behavior are studied. Aqueous Two-Phase Systems for Bioprocess Development for the Recovery of Biological Products addresses specific applications of ATPS for the recovery and partial purification of high molecular weight compounds such as proteins, nucleic acids and polysaccha...
Biological Materials Science
Takes a materials science approach, correlating structure-property relationships with function across a broad range of biological materials.
Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded
Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.
Contact Problems for Soft, Biological and Bioinspired Materials
This book contains contributions from leading researchers in biomechanics, nanomechanics, tribology, contact mechanics, materials science and applications on various experimental techniques including atomic force microscopy (AFM) for studying soft, biomimetic and biological materials and objects. Biologists, physicists, researchers applying methods of contact mechanics and researchers testing materials using indentation techniques along with many other applied scientists will find this book a useful addition to their libraries. Moreover, several reviews in this book are written as introductions to several important and rather sophisticated research areas such as depth-sensing indentation, studying of biological cells by AFM probes, mechanics of adhesive contact and contact between viscoelastic (hereditary elastic) solids. The book containing new theoretical models, results of experimental studies and numerical simulations, along with reviews of above mentioned areas of contact mechanics in application to biological systems, would be beneficial for researchers in many areas of biology, medicine, engineering, mechanics and biomimetics.
Regulation of Biological Control Agents
This book presents a comprehensive compilation of registration requirements necessary for authorisation of biological control agents (viruses, bacteria, fungi, active substances of natural origin and semiochemicals) in OECD countries. It also reviews data requirements for invertebrate agents (insect, mites and nematodes) and provides proposals for harmonisation of the regulation process and guidelines for completion of application forms. Based on results of the EU REBECA Policy Support Action, which gathered experts from academia, regulation authorities and industry, risks and benefits of the specific agents were reviewed and proposals for a more balanced registration process elaborated, including recommendations for acceleration of the authorisation process and discussions on trade-off effects and policy impacts. All these aspects are covered in detail in this book, which points the way forward for enhanced utilisation of biological control agents.
Biological Transformation
The global population is expected to rise to 9.8 billion by the year 2050 - with everyone ultimately striving for prosperity. New methods must therefore be found to achieve more efficient production. Research to date shows that the biological inventory that has evolved: its products, processes, principles and tools, can spur modern technology. The development of technological innovations based on biological concepts, with the goal of particularly innovative and sustainable value creation, today is collectively known as "biological transformation". It results in highly functional products with striking properties that can be both manufactured and utilized in a resource-saving way. In terms of taking responsibility of the good of all people, biological transformation is therefore a path that applied research will have to take. The Fraunhofer-Gesellschaft has recognized the developmental technology potential of biological transformation and sees it as its task not only to drive the relevant research forward, but also to promote public awareness of the topic.
