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 ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.

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 ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.

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.

The effort to understand and combat infectious diseases has, during the centuries, produced many key advances in science and medicine-including the development of vaccines, drugs, and other treatments. A subset of this research is conducted with agents that, like anthrax, not only pose a severe threat to the health of humans, plants, and animals but can also be used for ill-intended purposes. Such agents have been listed by the government as biological select agents and toxins. The 2001 anthrax letter attacks prompted the creation of new regulations aimed at increasing security for research with dangerous pathogens. The outcome of the anthrax letter investigation has raised concern about whether these measures are adequate. Responsible Research with Biological Select Agents and Toxins evaluates both the physical security of select agent laboratories and personnel reliability measures designed to ensure the trustworthiness of those with access to biological select agents and toxins. The book offers a set of guiding principles and recommended changes to minimize security risk and facilitate the productivity of research. The book recommends fostering a culture of trust and responsibility in the laboratory, engaging the community in oversight of the Select Agent Program, and enhancing the operation of the Select Agent Program.

Takes a materials science approach, correlating structure-property relationships with function across a broad range of biological materials.

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.

Design and Development of Biological, Chemical, Food and Pharmaceutical Products has been developed from course material from the authors’ course in Chemical and Biochemical Product Design which has been running at the Technical University Denmark for years. The book draws on the authors’ years of experience in academia and industry to provide an accessible introduction to this field, approaching product development as a subject in its own right rather than a sideline of process engineering In this subject area, practical experience is the key to learning and this textbook provides examples and techniques to help the student get the best out of their projects. Design and Development of Biological, Chemical, Food and Pharma Products aims to aid students in developing good working habits for product development. Students are challenged with examples of real problems that they might encounter as engineers. Written in an informal, student-friendly tone, this unique book includes examples of real products and experiences from real companies to bring the subject alive for the student as well as placing emphasis on problem solving and team learning to set a foundation for a future in industry. The book includes an introduction to the subject of Colloid Science, which is important in product development, but neglected in many curricula. Knowledge of engineering calculus and basic physical chemistry as well as basic inorganic and organic chemistry are assumed. An invaluable text for students of product design in chemical engineering, biochemistry, biotechnology, pharmaceutical sciences and product development. Uses many examples and case studies drawn from a range of industries. Approaches product development as a subject in its own right rather than a sideline of process engineering Emphasizes a problem solving and team learning approach. Assumes some knowledge of calculus, basic physical chemistry and basic transport phenomena as well as some inorganic and organic chemistry.

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 polysaccharides, particulate bioproducts such as cells and organelles and low molecular weight compounds. Non-conventional strategies involving ATPS such as affinity systems, continuous liquid-liquid fractionation stages and the recovery from plant extracts are presented. Economic analysis of the application of ATPS in comparison to other fractionation techniques, particularly liquid chromatography, is considered, as are opportunity and current trends in the ATPS research area. Each chapter utilizes the contributors' experimental expertise in traditional and non-conventional ATPS strategies, as well as analysis of areas of opportunity and perspectives on the development and future applications of ATPS in both the lab and larger scale operations. The result is a thorough and singular overview of ATPS which has not been matched by any other text on the market.

Comprehensive Natural Products III, Third Edition, Seven Volume Set updates and complements the previous two editions, including recent advances in cofactor chemistry, structural diversity of natural products and secondary metabolites, enzymes and enzyme mechanisms and new bioinformatics tools. Natural products research is a dynamic discipline at the intersection of chemistry and biology concerned with isolation, identification, structure elucidation, and chemical characteristics of naturally occurring compounds such as pheromones, carbohydrates, nucleic acids and enzymes. This book reviews the accumulated efforts of chemical and biological research to understand living organisms and their distinctive effects on health and medicine and to stimulate new ideas among the established natural products community. Provides readers with an in-depth review of current natural products research and a critical insight into the future direction of the field Bridges the gap in knowledge by covering developments in the field since the second edition published in 2010 Split into 7 sections on key topics to allow students, researchers and professionals to find relevant information quickly and easily Ensures that the knowledge within is easily understood by and applicable to a large audience

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.