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CAPA in the Pharmaceutical and Biotech Industries

CAPA in the Pharmaceutical and Biotech Industries Author J Rodriguez
ISBN-10 9781908818379
Release 2015-12-08
Pages 248
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CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes by revising procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. The reality is that the causes of the failure were never actually determined, therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations. Provides an understanding of the principles and techniques involved in the effective implementation of a CAPA program, from the identification of the problem, to the verification of preventive action Emphasis is placed on the practical aspects of how to perform failure investigations and root cause analysis through the use of several types of methodologies, all explained in detail Provides effective methods to use with a Corrective Action system to help quality professionals identify costly issues and resolve them quickly and appropriately



Outsourcing Biopharma R D to India

Outsourcing Biopharma R D to India Author P R Chowdhury
ISBN-10 9781908818010
Release 2011-05-05
Pages 130
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The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India. Constitutes the first ever comprehensive insight on the Indian biopharma sector Provides a perspective based on practical hands-on legal experience Simply structured, clearly presented and free from excessive legal jargon



Bioinformatics for Biomedical Science and Clinical Applications

Bioinformatics for Biomedical Science and Clinical Applications Author K-H Liang
ISBN-10 9781908818232
Release 2013-07-31
Pages 170
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Contemporary biomedical and clinical research is undergoing constant development thanks to the rapid advancement of various high throughput technologies at the DNA, RNA and protein levels. These technologies can generate vast amounts of raw data, making bioinformatics methodologies essential in their use for basic biomedical and clinical applications. Bioinformatics for biomedical science and clinical applications demonstrates what these cutting-edge technologies can do and examines how to design an appropriate study, including how to deal with data and address specific clinical questions. The first two chapters consider Bioinformatics and analysis of the human genome. The subsequent three chapters cover the introduction of Transcriptomics, Proteomics and Systems biomedical science. The remaining chapters move on to critical developments, clinical information and conclude with domain knowledge and adaptivity. A coherent presentation of concepts, methodologies and practical tools that systematically lead to significant discoveries in the biomedical and clinical area Real examples of cutting edge discoveries The introduction of study types and technologies for all the DNA, RNA and protein levels



Formulation tools for Pharmaceutical Development

Formulation tools for Pharmaceutical Development Author J E Aguilar
ISBN-10 9781908818508
Release 2013-09-30
Pages 304
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A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. Formulation tools for pharmaceutical development considers these key research and industrial tools. Nine chapters by leading contributors cover: Artificial neural networks technology to model, understand, and optimize drug formulations; ME_expert 2.0: a heuristic decision support system for microemulsions formulation development; Expert system for the development and formulation of push-pull osmotic pump tablets containing poorly water-soluble drugs; SeDeM Diagram: an expert system for preformulation, characterization and optimization of tables obtained by direct compression; New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression; and 3D-cellular automata in computer-aided design of pharmaceutical formulations: mathematical concept and F-CAD software. Coverage of artificial intelligence tools, new expert systems, understanding of pharmaceutical processes, robust development of medicines, and new ways to develop medicines Development of drugs and medicines using mathematical tools Compilation of expert system developed around the world



Computer Aided Applications in Pharmaceutical Technology

Computer Aided Applications in Pharmaceutical Technology Author Jelena Djuris
ISBN-10 9781908818324
Release 2013-04-10
Pages 300
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Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology. A comprehensive review of the current state of the art on various computer aided applications in pharmaceutical technology Case studies are presented in order to facilitate understanding of various concepts in computer-aided applications



Plasma Technologies for Textiles

Plasma Technologies for Textiles Author Roshan Shishoo
ISBN-10 9781845692575
Release 2007-02-21
Pages 360
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Plasma technologies present an environmentally-friendly and versatile way of treating textile materials in order to enhance a variety of properties such as wettability, liquid repellency, dyeability and coating adhesion. Recent advances made in commercially viable plasma systems have greatly increased the potential of using plasma technology in industrial textile finishing. This pioneering book provides an essential guide to both the technology and science related to plasmas and its practical applications in the textile industry. The first part of the book discusses the science and technology behind plasmas. Chapters give detailed and comprehensive descriptions on the characteristics of plasmas and methods of control and treatment in the processing of textiles. Both low pressure cold plasma and atmospheric pressure cold plasma processes are described as well as the diagnosis and control of plasma parameters in plasma generating reactors. A chapter is devoted to the use of plasma technology to achieve nanoscale treatment of textile surfaces. The second part of the book concentrates on specific applications of plasma technologies. Chapters cover treatments for water and oil repellency of textiles, engineering of biomedical textiles and woollen finishing techniques through the use of plasma technologies. Further chapters cover the modification of fibres for use in composites and the potential use of plasma technologies for the finishing of fabrics made of man made fibres. The final chapter in the book gives a comprehensive analysis of the surface chemical and physical characterisation of plasma treated fabrics. Written by a distinguished international team of experts, Plasma technologies for textiles is an invaluable reference for researchers, scientists and technologists alike. Summarises both the science and technology of plasma processing, and its practical applications Discusses how plasma technology improves textile properties such as wettability and liquid repelling An invaluable reference for researchers, scientists and technologists



Bioeconomy

Bioeconomy Author Iris Lewandowski
ISBN-10 9783319681528
Release 2017-12-11
Pages 356
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This book is open access under a CC BY 4.0 license. This book defines the new field of "Bioeconomy" as the sustainable and innovative use of biomass and biological knowledge to provide food, feed, industrial products, bioenergy and ecological services. The chapters highlight the importance of bioeconomy-related concepts in public, scientific, and political discourse. Using an interdisciplinary approach, the authors outline the dimensions of the bioeconomy as a means of achieving sustainability. The authors are ideally situated to elaborate on the diverse aspects of the bioeconomy. They have acquired in-depth experience of interdisciplinary research through the university’s focus on “Bioeconomy”, its contribution to the Bioeconomy Research Program of the federal state of Baden-Württemberg, and its participation in the German Bioeconomy Council. With the number of bioeconomy-related projects at European universities rising, this book will provide graduate students and researchers with background information on the bioeconomy. It will familiarize scientific readers with bioeconomy-related terms and give scientific background for economists, agronomists and natural scientists alike.



Biomaterials and Medical Devices

Biomaterials and Medical Devices Author Ferdiansyah Mahyudin
ISBN-10 9783319148458
Release 2016-03-29
Pages 242
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This book presents an introduction to biomaterials with the focus on the current development and future direction of biomaterials and medical devices research and development in Indonesia. It is the first biomaterials book written by selected academic and clinical experts experts on biomaterials and medical devices from various institutions and industries in Indonesia. It serves as a reference source for researchers starting new projects, for companies developing and marketing products and for governments setting new policies. Chapter one covers the fundamentals of biomaterials, types of biomaterials, their structures and properties and the relationship between them. Chapter two discusses unconventional processing of biomaterials including nano-hybrid organic-inorganic biomaterials. Chapter three addresses biocompatibility issues including in vitro cytotoxicity, genotoxicity, in vitro cell models, biocompatibility data and its related failure. Chapter four describes degradable biomaterial for medical implants, which include biodegradable polymers, biodegradable metals, degradation assessment techniques and future directions. Chapter five focuses on animal models for biomaterial research, ethics, care and use, implantation study and monitoring and studies on medical implants in animals in Indonesia. Chapter six covers biomimetic bioceramics, natural-based biocomposites and the latest research on natural-based biomaterials in Indonesia. Chapter seven describes recent advances in natural biomaterial from human and animal tissue, its processing and applications. Chapter eight discusses orthopedic applications of biomaterials focusing on most common problems in Indonesia, and surgical intervention and implants. Chapter nine describes biomaterials in dentistry and their development in Indonesia.



Cellulose Reinforced Nanofibre Composites

Cellulose Reinforced Nanofibre Composites Author Mohammad Jawaid
ISBN-10 9780081009659
Release 2017-06-06
Pages 548
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Cellulose-Reinforced Nanofibre Composites: Production, Properties and Applications presents recent developments in, and applications of, nanocellulose as reinforcement in composite and nanocomposite materials. Written by leading experts, the book covers properties and applications of nanocellulose, including the production of nanocellulose from different biomass resources, the usefulness of nanocellulose as a reinforcement for polymer and paper, and major challenges for successful scale-up production in the future. The chapters draw on cutting-edge research on the use of nanosized cellulose reinforcements in polymer composites that result in advanced material characteristics and significant enhancements in physical, mechanical and thermal properties. The book presents an up-to-date review of the major innovations in the field of nanocellulose and provides a reference material for future research in biomass based composite materials, which is timely due to the sustainable, recyclable and eco-friendly demand for highly innovative materials made from biomass. This book is an ideal source of information for scientific and industrial researchers working in materials science. Gathers together a broad spectrum of research on nanocellulose, with emphasis on the outstanding reinforcing potential when nanocellulose is included into a polymer matrix or as an additive to paper Demonstrates systematic approaches and investigations from processing, design, characterization and applications of nanocellulose Presents a useful reference and technical guide for nanocomposite materials R&D sectors, university academics and postgraduate students (Masters and PhD) and industrialists working in material commercialization



Lichen Secondary Metabolites

Lichen Secondary Metabolites Author Branislav Ranković
ISBN-10 9783319133744
Release 2014-12-31
Pages 202
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The present book discusses in detail the nature and bioactive properties of lichen secondary metabolites. Their therapeutic potential ranges from antibiotic to antioxidant and from anticarcinogenic to antiviral activity. It further discusses their use in traditional medicine and highlights possible future directions in the study of their pharmaceutical potential.



Metabolite Safety in Drug Development

Metabolite Safety in Drug Development Author Suzanne L. Iverson
ISBN-10 9781118949658
Release 2016-08-01
Pages 352
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A reference on drug metabolism and metabolite safety in the development phase, this book reviews the analytical techniques and experimental designs critical for metabolite studies. It features case studies of lessons learned and real world examples, along with regulatory perspectives from the US FDA and EMA. • Reviews the analytical techniques and experimental designs critical for metabolite studies • Covers methods including chirality, species differences, mass spectrometry, radiolabels, and in vitro / in vivo correlation • Discusses target pharmacology, in vitro systems aligned to toxicity tests, and drug-drug interactions • Includes perspectives from authors with firsthand involvement in industry and the study of drug metabolites, including viewpoints that have influenced regulatory guidelines



Natural Fibers Plastics and Composites

Natural Fibers  Plastics and Composites Author Frederick T. Wallenberger
ISBN-10 9781441990501
Release 2011-06-28
Pages 370
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Natural Fibers Plastics and Composites has been writing in one form or another for most of life. You can find so many inspiration from Natural Fibers Plastics and Composites also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Natural Fibers Plastics and Composites book for free.



Green Processes for Nanotechnology

Green Processes for Nanotechnology Author Vladimir A Basiuk
ISBN-10 9783319154619
Release 2015-03-25
Pages 446
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This book provides the state-of-the-art survey of green techniques in preparation of different classes of nanomaterials, with an emphasis on the use of renewable sources. Key topics covered include fabrication of nanomaterials using green techniques as well as their properties and applications, the use of renewable sources to obtain nanomaterials of different classes, from simple metal and metal oxide nanoparticles to complex bioinspired nanomaterials, economic contributions of nanotechnology to green and sustainable growth, and more. This is an ideal book for students, lecturers, researchers and engineers dealing with versatile (mainly chemical, biological, and medical) aspects of nanotechnology, including fabrication of nanomaterials using green techniques and their properties and applications.



Hybrid Polymer Composite Materials

Hybrid Polymer Composite Materials Author Vijay Kumar Thakur
ISBN-10 9780081007860
Release 2017-06-03
Pages 446
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Hybrid Polymer Composite Materials: Applications provides a clear understanding of the present state of-the-art and the growing utility of hybrid polymer composite materials. It includes contributions from world renowned experts and discusses the combination of different kinds of materials procured from diverse resources. In addition, this volume from the four volume series provides deep insights on the potential of hybrid polymer composite materials for advanced applications. Provides a clear understanding of the present state-of-the-art and the growing utility of hybrid polymer composite materials Includes contributions from world renowned experts and discusses the combination of different kinds of materials procured from diverse resources Discusses their synthesis, chemistry, processing, fundamental properties, and applications Provides insights on the potential of hybrid polymer composite materials for advanced applications



Small Molecule Medicinal Chemistry

Small Molecule Medicinal Chemistry Author Werngard Czechtizky
ISBN-10 9781118771570
Release 2015-09-21
Pages 528
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Stressing strategic and technological solutions to medicinal chemistry challenges, this book presents methods and practices for optimizing the chemical aspects of drug discovery. Chapters discuss benefits, challenges, case studies, and industry perspectives for improving drug discovery programs with respect to quality and costs. • Focuses on small molecules and their critical role in medicinal chemistry, reviewing chemical and economic advantages, challenges, and trends in the field from industry perspectives • Discusses novel approaches and key topics, like screening collection enhancement, risk sharing, HTS triage, new lead finding approaches, diversity-oriented synthesis, peptidomimetics, natural products, and high throughput medicinal chemistry approaches • Explains how to reduce design-make-test cycle times by integrating medicinal chemistry, physical chemistry, and ADME profiling techniques • Includes descriptive case studies, examples, and applications to illustrate new technologies and provide step-by-step explanations to enable them in a laboratory setting



Fundamentals of Food Biotechnology

Fundamentals of Food Biotechnology Author Byong H. Lee
ISBN-10 9781118384930
Release 2014-12-01
Pages 544
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Food biotechnology is the application of modern biotechnological techniques to the manufacture and processing of food, for example through fermentation of food (which is the oldest biotechnological process) and food additives, as well as plant and animal cell cultures. New developments in fermentation and enzyme technological processes, molecular thermodynamics, genetic engineering, protein engineering, metabolic engineering, bioengineering, and processes involving monoclonal antibodies, nanobiotechnology and quorum sensing have introduced exciting new dimensions to food biotechnology, a burgeoning field that transcends many scientific disciplines. Fundamentals of Food Biotechnology, 2nd edition is based on the author’s 25 years of experience teaching on a food biotechnology course at McGill University in Canada. The book will appeal to professional food scientists as well as graduate and advanced undergraduate students by addressing the latest exciting food biotechnology research in areas such as genetically modified foods (GMOs), bioenergy, bioplastics, functional foods/nutraceuticals, nanobiotechnology, quorum sensing and quenching. In addition, cloning techniques for bacterial and yeast enzymes are included in a “New Trends and Tools” section and selected references, questions and answers appear at the end of each chapter. This new edition has been comprehensively rewritten and restructured to reflect the new technologies, products and trends that have emerged since the original book. Many new aspects highlight the short and longer term commercial potential of food biotechnology.



Microbial Factories

Microbial Factories Author Vipin Chandra Kalia
ISBN-10 9788132225959
Release 2016-02-16
Pages 355
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This book highlights the efforts made by distinguished scientific researchers world-wide to meet two key challenges: i) the limited reserves of polluting fossil fuels, and ii) the ever-increasing amounts of waste being generated. These case studies have brought to the foreground certain innovative biological solutions to real-life problems we now face on a global scale: environmental pollution and its role in deteriorating human health. The book also highlights major advances in microbial metabolisms, which can be used to produce bioenergy, biopolymers, bioactive molecules, enzymes, etc. Around the world, countries like China, Germany, France, Sweden and the US are now implementing major national programs for the production of biofuels. The book provides information on how to meet the chief technical challenges – identifying an industrially robust microbe and cheap raw material as feed. Of the various possibilities for generating bioenergy, the most attractive is the microbial production of biohydrogen, which has recently gained significant recognition worldwide, due to its high efficiency and eco-friendly nature. Further, the book highlights factors that can make these bioprocesses more economical, especially the cost of the feed. The anaerobic digestion (AD) process is more advantageous in comparison to aerobic processes for stabilizing biowastes and producing biofuels (hydrogen, biodiesel, 1,3-propanediol, methane, electricity), biopolymers (polyhydroxyalkanoates, cellulose, exopolysaccharides) and bioactive molecules (such as enzymes, volatile fatty acids, sugars, toxins, etc.) for biotechnological and medical applications. Information is provided on how the advent of molecular biological techniques can provide greater insights into novel microbial lineages. Bioinformatic tools and metagenomic techniques have extended the limits to which these biological processes can be exploited to improve human welfare. A new dimension to these scientific works has been added by the emergence of synthetic biology. The Big Question is: How can these Microbial Factories be improved through metabolic engineering and what cost targets need to be met?