Refine Results
Sort By
From
To
Page 1
Page 1
Manufacturing of Pharmaceutical Proteins: From Technology to Economy
Manufacturing of Pharmaceutical Proteins: From Technology to Economy, renowned chemical engineer Dr. Stefan Behme delivers a comprehensive text covering all aspects of biopharmaceutical manufacturing, including legal and regulatory considerations, production facility design, quality assurance, supply chain management, emerging market regulations, and cost control.
Laboratory control system operations in a GMP environment
In Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS.
Cleaning validation : Practical compliance approaches for pharmaceutical manufacturing
Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. Encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and riskbased approaches to cleaning validation. Draws on the author’s vast experience in the field of cleaning validation and hazardous materials. Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. A diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products.
Cell-Cell Channels
The biological sciences are dominated by the idea that cells are the functionally autonomous, physically separated, discrete units of life. This concept was propounded in the 19th century by discoveries of the cellular structuring of both plants and animals. Moreover, the ap parent autonomy of unicellular eukaryotes, as well as the cellular basis of the mammalian brain (an organ whose anatomy for a long while defied attempts to validate the idea of the cellular nature of its neurons), seemed to provide the final conclusive evidence for the completeness of *cell theory', a theory which has persisted in an almost dogmatic form up to the present day. However, it is very obvious that there are numerous observations which indicate that it is not the cells which serve as the basic units of biological life but that this property falls to some other, subcellular assemblage. To deal with this intricate problem concerning the fundamental unit of living matter, we proposed the so-called Cell Body concept which, in fact, devel ops an exceedingly original idea proposed by Julius Sachs at the end of the 19th century. In the case of eukaryotic cells, DNA-enriched nuclei are intimately associated with a microtubular cytoskeleton. In this configuration—as a Cell Body—these two items comprise the fundamental functional and struc tural unit of eukaryotic living matter. The Cell Body seems to be inherent to all cells in all organisms.
Cancer cell biology : methods and protocols
Provides detailed methods on the mechanisms of underlying cancer cell biology. Chapters guide readers through techniques for culturing cancer cell lines, xenografts, cryopreservation of tumor cells, analyzing the co-culture of breast cancer cells, protein secretion by ELISA, flow cytometry-based, multi-parametric immunofluorescence analysis, protein expression by western blot, analysis of surface protein levels, protein recycling by biotinylation assay, and proteomics analysis by liquid chromatography-mass spectrometry.
Biosimilars : Regulatory, clinical, and biopharmaceutical development
Provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development.
Biopharmaceutical processing : Development, design, and Implementation of manufacturing processes
Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies.
Biopharmaceutical manufacturing progress, trends and challenges
Source of the latest innovative research and technical development in biomanufacturing systems. It is organised into 2 parts: 1) Manufacturing of recombinant therapeutic proteins (e.g. therapeutic antibodies, biosimilars/biogenerics) and 2) Manufacturing aspects of cell and gene therapy. Each with selected chapters on the following topics for both up- and downstream, such as: Advanced process strategies, especially continuous manufacturing, Advanced culture techniques, especially single-use systems, Process transfer, scale-up/scale-down models, Processing advances/Manufacturing productivity/efficiency, Model-assisted process understanding and development/Digital Twins, Process controls and analytics, Quality control, Quality by design, Facility design and full-scale commercial systems, manufacturing technology innovation.
Basic methods and protocols on Sourdough
Details traditional and modern approaches to characterize sourdough and to monitor its features during production, propagation and use, through state-of- the art analytical tools. Chapters guide reader through procedures to prepare and propagate the mature sourdough, to analyse and monitor microbiological, biochemical and rheology features of sourdough, sensory, and nutritional attributes of baked goods. Written in the format of the Methods and Protocols in Food Science series, chapters list necessary materials and methods for readily reproducible protocols.
Applied therapeutics : The clinical use of drugs
"Continually revised and updated for 50 years, Applied Therapeutics: The Clinical Use of Drugs is the gold standard for patient centered drug therapeutics. With its acclaimed case-based approach, it promotes mastery and application of the fundamentals of drug therapeutics. Featuring contributions from more than 200 experienced clinicians, every chapter reflects our ever-changing knowledge of drugs and the application of this knowledge to the individualized therapy of patients. As students progress from the General Principles section to chapters on specific diseases, they will benefit from practical problem-solving techniques that help devise effective evidence-based drug treatment plans"
3D printing of pharmaceutical and drug delivery devices progress from bench to bedside
Discover the latest, fast-developing technology to help move towards more cost-effective, small-batch, decentralized manufacturing of personalized systems . 3D printing has revolutionized manufacturing. Its precision and flexibility have enabled the large-scale production of materials and devices too complex for conventional industrial manufacturing. This has been particularly revolutionary in the field of pharmaceutical production, where 3D printing is being integrated into the manufacture of both drugs and drug delivery devices. It has never been more important for industry professionals to understand this form of production.
Blockchain, artificial intelligence, and the internet of things : Possibilities and opportunities
Provides basic concepts and deep knowledge about various security mechanisms that can be implemented in IoT through Blockchain technology. This book aids readers in gaining insight and knowledge about providing security and solutions to different challenges in IoT using Blockchain technology. This book primarily focuses on challenges to addressing the integration of the IoT with Blockchain with respect to potential benefits for IoT. This book gives descriptive analysis of Blockchain integrated with IoT applications and platforms for the development of IoT solutions along with possible topologies to that integration. Several application examples are included in a variety of industries / Provides the latest on secure IIoT communication using Blockchain technology for Industry 4.0 / Includes updates on using Blockchain technology in secure vehicular communication (VANET), healthcare, retail, and gaming / Provides the latest on secure IIoT communication using Blockchain technology for Industry 4.0
Machine-learning-assisted intelligent processing and optimization of complex systems
Focuses on the most recent developments in intelligent optimization methods and their applications in various test cases. The reprint covers various topics, including distributed multiagent modeling, metaheuristic algorithms, multisource data fusion, mobile computing and mobile sensing, machine learning-based intelligent processing for modeling complex manufacturing systems, and data-driven intelligent modeling
Machine Learning and Probabilistic Graphical Models for Decision Support Systems
Presents recent advancements in research, a review of new methods and techniques, and applications in decision support systems (DSS) with Machine Learning and Probabilistic Graphical Models, which are very effective techniques in gaining knowledge from Big Data and in interpreting decisions. It explores Bayesian network learning, Control Chart, Reinforcement Learning for multicriteria DSS, Anomaly Detection in Smart Manufacturing with Federated Learning, DSS in healthcare, DSS for supply chain management, etc. Researchers and practitioners alike will benefit from this book to enhance the understanding of machine learning, Probabilistic Graphical Models, and their uses in DSS in the context of decision making with uncertainty. The real-world case studies in various fields with guidance and recommendations for the practical applications of these studies are introduced in each chapter.
Law and the Semantic Web : Legal Ontologies, Methodologies, Legal Information Retrieval, and Applications
As part of this objective, ICT (information and communication technologies) services should become available for every citizen, and for all schools, homes and businesses. The book you have in front of you is about Semantic Web technology and law. Law is something omnipresent; all citizens — at some points in their lives — have to deal with it. In addition, law involves a large group of professionals, and is a mul- billion business world wide. Information technology is important because it that can improve citizens’ interaction with law, as well as improve legal professionals’ work environment. Legal professionals dedicate a significant amount of their time to finding, reading, analyzing and synthesizing information in order to take decisions, and prepare advice and trials, among other tasks. As part of the “Semantic-Based Knowledge and Content Systems” Strategic Objective, the European Commission is funding projects to construct technology to make the Semantic Web vision come true. 1 The articles in this book are related to two current foci of the Strategic Objective : • Knowledge acquisition and modelling, capturing knowledge from raw information and multimedia content in webs and other distributed repositories to turn poorly structured information into machi- processable knowledge.
Laser additive manufacturing: design, materials, processes and applications
Laser-based additive manufacturing (LAM) is a revolutionary advanced digital manufacturing technology developed in recent decades, which is also a key strategic technology for technological innovation and industrial sustainability. This technology unlocks the design and constraints of traditional manufacturing and meets the needs of complex geometry fabrication and high-performance part fabrication. A deeper understanding of the design, materials, processes, structures, properties and applications is desired to produce novel functional devices, as well as defect-free structurally sound and reliable LAM parts.The topics in this Special Issue reprint include macro- and micro-scale additive manufacturing with lasers, such as structure/material design, fabrication, modeling and simulation, in situ characterization of additive manufacturing processes and ex situ materials characterization and performance, with an overview that covers various applications in aerospace, biomedicine, optics and energy.
Knowledge and Skill Chains in Engineering and Manufacturing : Information Infrastructure in the Era of Global Communications
Explores knowledge and skill chains in engineering and manufacturing in the age of global communications. Information infrastructure involves a range of activities from product planning, engineering, and manufacturing trough transportation, marketing, and repair/upgrade to returns and recycling/disposal. Distinct from the traditional engineering database, life-cycle support information has its own characteristic requirements, -- flexible extensibility, distributed architecture, multiple viewpoints, long-time archiving, and product usage information. Several authors address the architecture of the information infrastructure, its services and its requirements. Other papers focus on the knowledge and skill chains that develop in a variety of situations: the supply chain, the factory floor, the man-system interaction, etc. For each of these, state-of-the-art and state-of-research scenarios for various industrial sectors address both engineering and operations requirements in the current socio-economic environment.
Computation Engineering : Applied Automata Theory and Logic
This book covers automata in depth, providing good intuitions along the way, and culminating with applications that are used every day in the field. In this respect, it is a departure from the conventional textbooks on complexity and computability, although these 'tradtional' aspects remain well represented.
Boundary Representation Modelling Techniques
Boundary representation is the principle solid modelling method used in modern CAD/CAM systems. There have been a long series of developments on which currently available systems are based, full details of which are only partially known. Ian Stroud’s thorough coverage of these developments puts this technology in perspective. Ian Stroud started working with boundary representation solid modelling in 1977. Since then he has researched and is researching a wide variety of topics in and around this field. The information in the book comes from the results of this research.
Beginning C : From novice to professional
With Beginning C: From Novice to Professional, Fourth Edition, you'll come to understand the fundamentals of the C language and learn how to program. All you need is this book and any one of the widely available free or commercial C or C++ compilers, and you'll soon be writing real C programs. You'll learn C from the first principles.
