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In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

Medicine. --- Pharmaceutical technology. --- Biomedicine. --- Pharmaceutical Sciences/Technology. --- Pharmaceutical biotechnology. --- Proteins --- Biotechnology. --- Biopharmaceutical technology --- Drugs --- Biotechnology --- Pharmaceutical technology --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Technology

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This introductory text explains both the basic science and the applications of biotechnology derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those who did not receive formal training in this field. Pharmaceutical Biotechnology: Fundamentals and Applications, Fifth Edition completely updates the previous edition, and includes additional coverage on newer approaches such as oligonucleotides, mi/siRNA, gene therapy and advanced therapeutics. Daan J.A. Crommelin is Professor Emeritus Department of Pharmaceutical Sciences, Utrecht Institute for Pharmaceutical Sciences at Utrecht University, Utrecht, The Netherlands and Adjunct Professor in the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah, Salt Lake City, UT, USA Robert D. Sindelar is Professor and former Dean Faculty of Pharmaceutical Sciences and The Centre for Health Evaluation & Outcomes Sciences (CHEOS), The University of British Columbia (UBC), Vancouver, BC, Canada and President of the Global Drug Commercialization Centre (GDCC)-China and Vice-President GDCC-worldwide, Chengdu, China Bernd Meibohm is Professor of Pharmaceutical Sciences and Associate Dean for Research and Graduate Programs at the University of Tennessee Health Science Center, College of Pharmacy, Memphis, TN, USA.

Pharmaceutical technology. --- Biomedical engineering. --- Pharmaceutical Sciences/Technology. --- Biomedical Engineering/Biotechnology. --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Technology --- Clinical engineering --- Medical engineering --- Bioengineering --- Biophysics --- Engineering --- Medicine --- Pharmaceutical biotechnology. --- Biopharmaceutical technology --- Drugs --- Biotechnology --- Pharmaceutical technology

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The 18th ESACT meeting was celebrated in Granada (Spain) in May 2003, and was entitled "Animal Cell Technology Meets Genomics", in order to reflect that the emerging technologies in the area of genomics, proteomics and other "-omics"-type disciplines will provide key technological assets to increase knowledge and open new horizons in animal cell technology. During the meeting a variety of top-class emerging technologies were presented together with the latest advances in more mature industrial areas. The meeting was opened by a first session devoted to the understanding of basic cellular mechanisms, and four sessions focused on applied aspects of animal cell technology: Cell-based therapies and gene-based therapies, target discovery and biopharmaceuticals. The Granada Meeting has also seen a special focus on forefront industrial case studies. The spirit and scientific excellence of the 18th ESACT meeting is now reflected in different chapters of the book. The book presents, in form of short papers, a high number of the contributions to the meeting, and has been prepared with the aim to provide a relevant reference of the current research efforts in Animal Cell Technology.

Animal cell biotechnology --- Pharmaceutical biotechnology --- Genomics --- Biopharmaceutical technology --- Drugs --- Biotechnology --- Pharmaceutical technology --- Biotechnology. --- Zoology. --- Biochemistry. --- Animal genetics. --- Proteomics. --- Biochemistry, general. --- Animal Genetics and Genomics. --- Animal Biochemistry. --- Molecular biology --- Proteins --- Genetics --- Biological chemistry --- Chemical composition of organisms --- Organisms --- Physiological chemistry --- Biology --- Chemistry --- Medical sciences --- Natural history --- Animals --- Chemical engineering --- Genetic engineering --- Composition

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Yan Wang, De-Dong Li, Yuan-Ying Jiang and Eleftherios Mylonakis Utility of Insects for Studying Human Pathogens and Evaluating New Antimicrobial Agents Krishnendu Mukherjee, Ramya Raju, Rainer Fischer and Andreas Vilcinskas Galleria Mellonella as a Model Host to Study Gut Microbe Homeostasis and Brain Infection by the Human Pathogen Listeria Monocytogenes DisordersJulia Hoffmann, Renja Romey, Christine Fink and Thomas Roeder Drosophila as a Model to Study Metabolic Annely Brandt and Andreas Vilcinskas The Fruit Fly Drosophila melanogaster as a Model for Aging Research Theodoulakis Christofi and Yiorgos Apidianakis Drosophila and the Hallmarks of Cancer Stefanie Grünwald, Iris V. Adam, Ana-Maria Gurmai, Ludmila Bauer, Michael Boll, and Uwe Wenzel The red flour beetle Tribolium castaneum as a model to monitor food safety and functionality Alexander O. Brachmann and Helge B. Bode Identification and Bioanalysis of Natural Products from Insect Symbionts and Pathogens Jette Pretzel, Franziska Mohring, Stefan Rahlfs and Katja Becker Antiparasitic Peptides.

Chemistry. --- Biotechnology. --- Applied Ecology. --- Biomedical engineering. --- Biomedical Engineering. --- Mechanical Engineering --- Engineering & Applied Sciences --- Bioengineering --- Clinical engineering --- Medical engineering --- Applied ecology. --- Insect cell biotechnology. --- Pharmaceutical biotechnology. --- Ecology --- Environmental protection --- Nature conservation --- Biopharmaceutical technology --- Drugs --- Biotechnology --- Pharmaceutical technology --- Insect cells in biotechnology --- Animal cell biotechnology --- Biomedical Engineering and Bioengineering. --- Biophysics --- Engineering --- Medicine --- Chemical engineering --- Genetic engineering --- Chimie --- Biotechnologie --- Génie biomédical

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Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule” valid for small chemical entities.   In response, a dedicated regulation was issued in the European Union. It is based on the concept of “biological medicinal products similar to a biological reference product”, or “biosimilars”. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature.   This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.

Biologicals. --- Biomedical engineering -- Congresses. --- Diagnostic imaging. --- Biologicals --- Medicine --- Health & Biological Sciences --- Pharmacy, Therapeutics, & Pharmacology --- Oncology --- Generic drugs --- Pharmaceutical biotechnology --- Patent medicines --- Medicines, Patent, proprietary, etc. --- Proprietary drugs --- Proprietary medicines --- Biopharmaceutical technology --- Drugs --- Generic equivalents (Drugs) --- Generics (Drugs) --- Biotechnology --- Pharmacy. --- Medicine. --- Immunology. --- Pharmaceutical technology. --- Nephrology. --- Oncology. --- Medicine & Public Health. --- Pharmaceutical Sciences/Technology. --- Drugs, Nonprescription --- Pharmaceutical technology --- Generic products --- Generic substitution