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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.
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.
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.
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.
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.
Artificial Intelligence for Cloud and Edge Computing
Discusses the future possibilities of AI with cloud computing and edge computing. Aims to conduct analyses, implementation and discussion of many tools (of artificial intelligence, machine learning and deep learning and cloud computing, fog computing, and edge computing including concepts of cyber security) for understanding integration of these technologies. Readers can quickly get an overview of these emerging topics and get many ideas of the future of AI with cloud, edge, and in many other areas. Topics include machine and deep learning techniques for Internet of Things based cloud systems; security, privacy and trust issues in AI based cloud and IoT based cloud systems; AI for smart data storage in cloud-based IoT; blockchain based solutions for AI based cloud and IoT based cloud systems.This book is relevent to researchers, academics, students, and professionals. Presents fusion of cloud computing services and AI technology for bringing a significant change in the technology industry; Includes self-assessment problems for increasing knowledge of real world problems, i.e., how AI and cloud/edge computing can change business for the better; Provides innovative results of integrations of AI in other applications such as healthcare, finance, manufacturing, transportation, agriculture, etc.
Artificial Intelligence and Cybersecurity : Advances and Innovations
Provides advanced system implementation for Smart Cities using artificial intelligence. It addresses the complete functional framework workflow and explores basic and high-level concepts. The book is based on the latest technologies covering major challenges, issues and advances, and discusses intelligent data management and automated systems.
Analysis and Development of Sustainable Urban Production Systems
Manufacturing of products in urban production sites is connected to unique potentials, yet also to specific challenges. Urban factories can provide functional diversity and contribute positive impacts to a city. The concept of urban production receives rising attention in research and industry and it is recognized in its interdisciplinary nature. With a holistic approach from both the urban perspective and the factory perspective, negative impacts can be minimized, positive effects enabled and mutually beneficial, symbiotic combinations created. The presented framework and methods for the evaluation and implementation of sustainable urban production systems allow the assessment of impacts and provide the means to control and utilize the unique strengths of urban factories for cities and industry. This will allow a structured derivation of methods and measures from the concept of urban production for producing enterprises and the urban stakeholders.
Advances in Production Technology
This edited volume contains the selected papers presented at the scientific board meeting of the German Cluster of Excellence on “Integrative Production Technology for High-Wage Countries”, held in November 2014. The topical structure of the book is clustered in six sessions: Integrative Production Technology, Individualised Production, Virtual Production Systems, Integrated Technologies, Self-Optimising Production Systems and Human Factors in Production Technology. The Aachen perspective on a holistic theory of production is complemented by conference papers from external leading researchers in the fields of production, materials science and bordering disciplines.
Advanced manufacturing technology and systems
Advanced manufacturing technology and systems cover a broad scope involving manufacturing processes, machine tool design, system optimization, smart and flexible manufacturing, theoretical study and metrology. This reprint comprises 19 original papers concerning recent advances in the research and development of AMTSs. Specifically, there are many research fields that are covered: machining processes (six papers), micro-/nano-precision fabrication (four papers), and system optimization (eight papers), in addition to one review.
3D Printing in Oral Health Science : Applications and Future Directions
Equips readers with a sound understanding of contemporary clinical applications in all fields of dentistry and their future directions. In the last few years, the development of 3D printing for medical and dental applications has increased tremendously. Advancements in 3D printing create the possibility of customized products, savings on small-scale productions, ease of sharing and processing of patient image data, and educational up-gradation. Looking at the dental specialties, it is evident that 3D printing has applications in all aspects of oral health science including prosthodontics, oral surgery, periodontics, endodontics, and orthodontics. This book will cover all major fields in dentistry and will help the practitioner in the process of decision-making and apply concepts in clinical or laboratory practice. It is based on current scientific evidence to provide readers with an up-to-date contemporary underst
