Download or read book Lean Biomanufacturing written by Nigel J Smart and published by Elsevier. This book was released on 2013-10-31 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful.Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing. A focus on the issues associated with the application of lean principles to biomanufacturing Practical examples of factors which can affect biopharmaceutical processes Coverage of key factors which require integration to run an efficient biopharmaceutical process

Download or read book Process Control Intensification and Digitalisation in Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2021-12-15 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing Explore new trends in continuous biomanufacturing with contributions from leading practitioners in the field With the increasingly widespread acceptance and investment in the ??technology, the last decade has demonstrated the utility of continuous ??processing in the pharmaceutical industry. In Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing, distinguished biotechnologist Dr. Ganapathy Subramanian delivers a comprehensive exploration of the potential of the continuous processing of biological products and discussions of future directions in advancing continuous processing to meet new challenges and demands in the manufacture of therapeutic products. A stand-alone follow-up to the editor’s Continuous Biomanufacturing: Innovative Technologies and Methods published in 2017, this new edited volume focuses on critical aspects of process intensification, process control, and the digital transformation of biopharmaceutical processes. In addition to topics like the use of multivariant data analysis, regulatory concerns, and automation processes, the book also includes: Thorough introductions to capacitance sensors to control feeding strategies and the continuous production of viral vaccines Comprehensive explorations of strategies for the continuous upstream processing of induced microbial systems Practical discussions of preparative hydrophobic interaction chromatography and the design of modern protein-A-resins for continuous biomanufacturing In-depth examinations of bioprocess intensification approaches and the benefits of single use for process intensification Perfect for biotechnologists, bioengineers, pharmaceutical engineers, and process engineers, Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing is also an indispensable resource for chemical engineers seeking a one-stop reference on continuous biomanufacturing.

Download or read book Emerging Technologies in Manufacturing written by Matthew N. O. Sadiku and published by Springer Nature. This book was released on 2023-03-15 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: The manufacturing industry is a cornerstone of national economy and people’s livelihood. It is the way of transforming resources into products or goods which are required to cater to the needs of the society. Traditional manufacturing companies currently face several challenges such as rapid technological changes, inventory problem, shortened innovation, short product life cycles, volatile demand, low prices, highly customized products, and ability to compete in the global markets. Modern manufacturing is highly competitive due to globalization and fast changes in the global market. This book reviews emerging technologies in manufacturing. These technologies include artificial intelligence, smart manufacturing, lean manufacturing, robotics, automation, 3D printing, nanotechnology, industrial Internet of things, and augmented reality. The use of these technologies will have a profound impact on the manufacturing industry. The book consists of 19 chapters. Each chapter addresses a single emerging technology in depth and describes how manufacturing organizations are adopting the technology. The book fills an important niche for manufacturing. It is a comprehensive, jargon-free introductory text on the issues, ideas, theories, and problems on emerging technologies in manufacturing. It is a must-read book for beginners or anyone who wants to be updated about emerging technologies.

Download or read book Stem Cell Bioprocessing written by Tiago G. Fernandes and published by Elsevier. This book was released on 2013-11-15 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Stem cell bioprocessing describes the main large-scale bioprocessing strategies for both stem cell culture and purification, envisaging the application of these cells for regenerative medicine and drug screening. Bioreactor configurations are described, including their applications for stem cell expansion, and stem cell separation techniques such as isolation and purification are discussed. Basic definitions are provided concerning the different types of stem cells, from adult stem cells to the more recent induced pluripotent stem cells. The main characteristics of these different stem cell types are described, alongside the molecular mechanisms underlying their self-renewal and differentiation. The book also focuses on methodologies currently used for in vitro stem cell culture under static conditions, including the challenge of xeno-free culture conditions, as well as culture parameters that influence stem cell culture. Approaches for both stem cell culture and separation in micro-scale conditions are presented, including the use of cellular microarrays for high-throughput screening of the effect of both soluble and extracellular matrix molecules. A further section is dedicated to application of stem cells for regenerative medicine. Maintains a unique focus on both the basic stem cell biology concepts, and their translation to large-scale bioprocessing approaches Envisages the use of stem cells in regenerative medicine and drug screening applications Discusses the application of microscale techniques as a tool to perform basic stem cell biology studies

Download or read book CAPA in the Pharmaceutical and Biotech Industries written by J Rodriguez and published by Elsevier. This book was released on 2015-12-08 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Process Scale Purification of Antibodies written by Uwe Gottschalk and published by John Wiley & Sons. This book was released on 2017-03-02 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt: Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing

Download or read book Operations Research written by Kuodi Jian and published by BoD – Books on Demand. This book was released on 2016-12-28 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is dedicated to operations research of broad applications, such as improving informational bases of performance measurement with grey relational analysis, application of lean methodologies in a neurosurgery high dependency unit, iteration algorithms in Markov decision processes with state-action-dependent discount factors and unbounded costs, financial feasibility analysis of Natura Rab business case study, and mathematical modeling of isothermal drying and its potential application in the design of the industrial drying regimes of clay products.Operations research is an important topic. In addition to its obvious benefits of winning a war, making most profit in a business endeavor, and constructing a correct mathematical model, it also provides a tool for efficient use of natural resources. Furthermore, both theory and practice of operations research and its related concepts are covered in the book, and a reader can benefit from this balanced coverage.

Download or read book From Plant Genomics to Plant Biotechnology written by Palmiro Poltronieri and published by Elsevier. This book was released on 2013-08-31 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the appearance of methods for the sequencing of genomes and less expensive next generation sequencing methods, we face rapid advancements of the -omics technologies and plant biology studies: reverse and forward genetics, functional genomics, transcriptomics, proteomics, metabolomics, the movement at distance of effectors and structural biology. From plant genomics to plant biotechnology reviews the recent advancements in the post-genomic era, discussing how different varieties respond to abiotic and biotic stresses, understanding the epigenetic control and epigenetic memory, the roles of non-coding RNAs, applicative uses of RNA silencing and RNA interference in plant physiology and in experimental transgenics and plants modified to specific aims. In the forthcoming years these advancements will support the production of plant varieties better suited to resist biotic and abiotic stresses, for food and non-food applications. This book covers these issues, showing how such technologies are influencing the plant field in sectors such as the selection of plant varieties and plant breeding, selection of optimum agronomic traits, stress-resistant varieties, improvement of plant fitness, improving crop yield, and non-food applications in the knowledge based bio-economy. Discusses a broad range of applications: the examples originate from a variety of sectors (including in field studies, breeding, RNA regulation, pharmaceuticals and biotech) and a variety of scientific areas (such as bioinformatics, -omics sciences, epigenetics, and the agro-industry) Provides a unique perspective on work normally performed 'behind closed doors'. As such, it presents an opportunity for those within the field to learn from each other, and for those on the 'outside' to see how different groups have approached key problems Highlights the criteria used to compare and assess different approaches to solving problems. Shows the thinking process, practical limitations and any other considerations, aiding in the understanding of a deeper approach

Download or read book Matlab in Bioscience and Biotechnology written by Leonid Burstein and published by Elsevier. This book was released on 2011-06-05 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: MATLAB® in bioscience and biotechnology presents an introductory Matlab course oriented towards various collaborative areas of biotechnology and bioscience. It concentrates on Matlab fundamentals and gives examples of its application to a wide range of current bioengineering problems in computational biology, molecular biology, bio-kinetics, biomedicine, bioinformatics, and biotechnology. In the last decade Matlab has been presented to students as the first computer program they learn. Consequently, many non-programmer students, engineers and scientists have come to regard it as user-friendly and highly convenient in solving their specific problems. Numerous books are available on programming in Matlab for engineers in general, irrespective of their specialization, or for those specializing in some specific area, but none have been designed especially for such a wide, interdisciplinary, and topical area as bioengineering. Thus, in this book, Matlab is presented with examples and applications to various school-level and advanced bioengineering problems - from growing populations of microorganisms and population dynamics, reaction kinetics and reagent concentrations, predator-prey models, mass-transfer and flow problems, to sequence analysis and sequence statistics. This is the first book intended as a manual introducing biologists and other biotechnology engineers to work with Matlab It is suitable for beginners and inexperienced users; however, applications of Matlab to advanced problems such as the Monte Carlo method, curve fitting, and reliable machine diagnostics make the book relevant to university teachers as well The book is different in that it assumes a modest mathematical background for the reader and introduces the mathematical or technical concepts with a somewhat traditional approach; Matlab is then used as a tool for subsequent computer solution

Download or read book Outsourcing Biopharma R D to India written by P R Chowdhury and published by Elsevier. This book was released on 2011-05-05 with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Practical Leadership for Biopharmaceutical Executives written by Jane Y Chin and published by Elsevier. This book was released on 2011-05-05 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biohealthcare executive in upper-middle management confronts leadership challenges unique to their industry: they manage highly specialized knowledge workers and innovators, compete at the speed of technology, work in a highly regulated environment where "free speech" often does not apply due to patient safety and privacy concerns, and increasingly are leading virtual teams who may be located in different parts of the world. Practical leadership for biopharmaceutical executives is a guide that strips away the theory and meets head-on the practical leadership challenges these executives face on a daily basis, and provides these "innovator leaders" with the tools to lead effectively in the face of technological complexity. Focuses on personal leadership, where the executive has an opportunity to manage his/her own effectiveness as a leader and manager, and engage with their own career development and method of contribution within their chosen industry Discusses particularly the unique leadership challenges in biohealthcare: an industry that is at once highly innovative and emotive. Biohealthcare companies are often viewed with suspicion by the consumers who question corporate motives, and product marketing and sales practices. The effective biohealthcare leaders are well aware of these emotive features, and embody ethics through action - not just lip service Includes real life examples, including a series of both phone-based and email-based interviews of executives

Download or read book NMR Metabolomics in Cancer Research written by Miroslava Čuperlović-Culf and published by Elsevier. This book was released on 2012-12-17 with total page 446 pages. Available in PDF, EPUB and Kindle. Book excerpt: The application of nuclear magnetic resonance (NMR) metabolomics in cancer research requires an understanding of the many possibilities that NMR metabolomics can offer, as well as of the specific characteristics of the cancer metabolic phenotype and the open questions in cancer research. NMR metabolomics in cancer research presents a detailed account of the NMR spectroscopy methods applied to metabolomics mixture analysis along with a discussion of their advantages and disadvantages. Following an overview of the potential use of NMR metabolomics in cancer research, the book begins with an examination of the cancer metabolic phenotype and experimental methodology, before moving on to cover data pre-processing and data analysis. Chapters in the latter part of the book look at dynamic metabolic profiling, biomarker discovery, and the application of NMR metabolomics for different types of cancer, before a concluding chapter discusses future perspectives in the field. Focused description of NMR spectroscopy needed by cancer biologists who are starting to use metabolomics Current overview of knowledge related to the cancer metabolic phenotype from the perspective of metabolomics applications Information about the best practices in NMR metabolomics experimentation and data preprocessing as applied to different sample types

Download or read book Ocular Transporters and Receptors written by Ashim K Mitra and published by Elsevier. This book was released on 2013-10-31 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ocular transporters and receptors contains detailed descriptions of major transporters and receptors expressed in the eye, with special emphasis on their role in drug delivery. The complex anatomy and the existence of multiple barriers in the eye pose a considerable challenge to successful drug delivery to the eye. Hence ocular transporters and receptors are important targets for drug delivery. A significant advancement has been made in the field of ocular transport research and their role in drug delivery. In this book the cutting edge research being carried out in this field is compiled and summarized. The book focuses on key areas, including the anatomy and physiology of the eye, biology of ocular transporters and receptors, techniques in characterization of transporters and receptors, transporters and receptors in the anterior and posterior segment in the eye, the role of ocular transporters and receptors in drug delivery, and transporter-metabolism interplay in the eye. Highly focused on ocular transporters Most up-to-date research compilation Detailed description of role of transporters and receptors in ocular drug discovery and delivery

Download or read book Nanoparticulate Drug Delivery written by Vandana Patravale and published by Elsevier. This book was released on 2012-10-31 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nanotechnology-based therapeutics, operating at scales of billionths of a metre, have great potential for future expansion in altering the scale and methods of drug delivery. The availability of these novel formulations to once-inaccessible areas of the body has greatly expanded the therapeutic window of existing drug molecules. Nanoparticulate drug delivery highlights and examines the transition of nanoparticulate drug delivery systems from the laboratory into a commercially viable sector. The first chapters of the book provide an overview of the use and characterization of nanoparticulate systems as drug carriers, including the assessment of their morphology, sterility and potential toxicity. In the latter part of the book, chapters cover nanotoxicology, regulatory aspect and clinical trials, ending with an overview of several case studies and a look towards future developments. Discusses the issues surrounding nanoparticulate products, based on personal experience of their formulation Provides an overview of new application areas, including RNA interference Outlines the pros and cons of nanoparticulate products, and discusses how these may influence their route into the commercial sector

Download or read book Open Source Software in Life Science Research written by Lee Harland and published by Elsevier. This book was released on 2012-10-31 with total page 583 pages. Available in PDF, EPUB and Kindle. Book excerpt: The free/open source approach has grown from a minor activity to become a significant producer of robust, task-orientated software for a wide variety of situations and applications. To life science informatics groups, these systems present an appealing proposition - high quality software at a very attractive price. Open source software in life science research considers how industry and applied research groups have embraced these resources, discussing practical implementations that address real-world business problems. The book is divided into four parts. Part one looks at laboratory data management and chemical informatics, covering software such as Bioclipse, OpenTox, ImageJ and KNIME. In part two, the focus turns to genomics and bioinformatics tools, with chapters examining GenomicsTools and EBI Atlas software, as well as the practicalities of setting up an ‘omics’ platform and managing large volumes of data. Chapters in part three examine information and knowledge management, covering a range of topics including software for web-based collaboration, open source search and visualisation technologies for scientific business applications, and specific software such as DesignTracker and Utopia Documents. Part four looks at semantic technologies such as Semantic MediaWiki, TripleMap and Chem2Bio2RDF, before part five examines clinical analytics, and validation and regulatory compliance of free/open source software. Finally, the book concludes by looking at future perspectives and the economics and free/open source software in industry. Discusses a broad range of applications from a variety of sectors Provides a unique perspective on work normally performed behind closed doors Highlights the criteria used to compare and assess different approaches to solving problems

Download or read book Bioinformatics for Biomedical Science and Clinical Applications written by K-H Liang and published by Elsevier. This book was released on 2013-07-31 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Sterility Sterilisation and Sterility Assurance for Pharmaceuticals written by Tim Sandle and published by Elsevier. This book was released on 2013-10-31 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products