Lean Biomanufacturing Book

Lean Biomanufacturing


  • Author : Nigel J Smart
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • Genre: Science
  • Pages : 384
  • ISBN 10 : 9781908818409

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Lean Biomanufacturing 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

Process Control  Intensification  and Digitalisation in Continuous Biomanufacturing Book

Process Control Intensification and Digitalisation in Continuous Biomanufacturing


  • Author : Ganapathy Subramanian
  • Publisher : John Wiley & Sons
  • Release Date : 2021-12-15
  • Genre: Technology & Engineering
  • Pages : 400
  • ISBN 10 : 9783527827336

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Process Control Intensification and Digitalisation in Continuous Biomanufacturing 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.

From Plant Genomics to Plant Biotechnology Book

From Plant Genomics to Plant Biotechnology


  • Author : Palmiro Poltronieri
  • Publisher : Elsevier
  • Release Date : 2013-08-31
  • Genre: Science
  • Pages : 274
  • ISBN 10 : 9781908818478

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From Plant Genomics to Plant Biotechnology 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 considerati

Matlab   in Bioscience and Biotechnology Book

Matlab in Bioscience and Biotechnology


  • Author : Leonid Burstein
  • Publisher : Elsevier
  • Release Date : 2011-06-05
  • Genre: Science
  • Pages : 268
  • ISBN 10 : 9781908818034

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Matlab in Bioscience and Biotechnology 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

Process Scale Purification of Antibodies Book

Process Scale Purification of Antibodies


  • Author : Uwe Gottschalk
  • Publisher : John Wiley & Sons
  • Release Date : 2017-04-03
  • Genre: Medical
  • Pages : 752
  • ISBN 10 : 9781119126911

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Process Scale Purification of Antibodies 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

Operations Research Book

Operations Research


  • Author : Kuodi Jian
  • Publisher : BoD – Books on Demand
  • Release Date : 2016-12-28
  • Genre: Mathematics
  • Pages : 142
  • ISBN 10 : 9789535128175

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Operations Research 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.

Process Architecture in Biomanufacturing Facility Design Book

Process Architecture in Biomanufacturing Facility Design


  • Author : Jeffery Odum
  • Publisher : John Wiley & Sons
  • Release Date : 2018-01-26
  • Genre: Science
  • Pages : 384
  • ISBN 10 : 9781118833650

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Process Architecture in Biomanufacturing Facility Design Excerpt :

Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature—and it’s rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements. Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future. Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO—especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies Includes many diagrams that clarify the design app

NMR Metabolomics in Cancer Research Book

NMR Metabolomics in Cancer Research


  • Author : Miroslava Čuperlović-Culf
  • Publisher : Elsevier
  • Release Date : 2012-12-17
  • Genre: Medical
  • Pages : 446
  • ISBN 10 : 9781908818263

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NMR Metabolomics in Cancer Research 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

Bioinformatics for Biomedical Science and Clinical Applications Book

Bioinformatics for Biomedical Science and Clinical Applications


  • Author : K-H Liang
  • Publisher : Elsevier
  • Release Date : 2013-07-31
  • Genre: Computers
  • Pages : 170
  • ISBN 10 : 9781908818232

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Bioinformatics for Biomedical Science and Clinical Applications 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

Formulation tools for Pharmaceutical Development Book

Formulation tools for Pharmaceutical Development


  • Author : J E Aguilar
  • Publisher : Elsevier
  • Release Date : 2013-09-30
  • Genre: Medical
  • Pages : 304
  • ISBN 10 : 9781908818508

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Formulation tools for Pharmaceutical Development Excerpt :

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

Sterility  Sterilisation and Sterility Assurance for Pharmaceuticals Book
Score: 5
From 1 Ratings

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals


  • Author : Tim Sandle
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • Genre: Medical
  • Pages : 362
  • ISBN 10 : 9781908818638

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Sterility Sterilisation and Sterility Assurance for Pharmaceuticals 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

Marine Enzymes for Biocatalysis Book

Marine Enzymes for Biocatalysis


  • Author : Antonio Trincone
  • Publisher : Elsevier
  • Release Date : 2013-09-30
  • Genre: Science
  • Pages : 576
  • ISBN 10 : 9781908818355

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Marine Enzymes for Biocatalysis Excerpt :

Marine bioprospecting is a highly topical subject - in both applied and basic research - but, as yet, the marine ecosystem is a relatively unexplored source of natural bioactive substances with potential therapeutic activity. This book addresses the use of marine enzymes in biocatalysis through a series of chapters from leading scientists within academic and industrial fields. Biocatalytic processes can take advantage of the habitat-related properties of marine enzymes, such as salt tolerance, hyperthermostability, barophilicity, cold adaptivity, and so on, whilst also taking into consideration substrate specificity and affinity. These evolved properties are linked to the metabolic functions of the enzymes and to the ecological aspects of the natural source. New properties can also be discovered at the molecular level of catalysis, particularly concerning the stereochemical characteristics of products. Marine enzymes for biocatalysis initially examines the nature and level of interest in marine biological diversity, and outlines the fundamentals of biocatalysis. It goes on to detail sources of marine enzymes, and to analyse examples from both chemical and stereochemical viewpoints of catalysis, including microbial enzymes and animal or plant sources. The book goes on to explore the future potential of marine bioprospecting in biocatalysis. Compiles studies from leading scientists in a direct and accessible format. Includes practical descriptions of results, adding further details not often covered in formal articles Takes a molecular view which fully explains the enzymatic aspects of reactions, particularly regarding biocatalytic characteristics and descriptions of bioprocesses Selects examples of chemical and stereochemical aspects of enzymatic action with respect to known terrestrial counterparts

Ocular Transporters and Receptors Book

Ocular Transporters and Receptors


  • Author : Ashim K Mitra
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • Genre: Science
  • Pages : 276
  • ISBN 10 : 9781908818317

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Ocular Transporters and Receptors 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

Bacterial Cellular Metabolic Systems Book

Bacterial Cellular Metabolic Systems


  • Author : K. Shimizu
  • Publisher : Elsevier
  • Release Date : 2013-03-26
  • Genre: Science
  • Pages : 496
  • ISBN 10 : 9781908818201

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Bacterial Cellular Metabolic Systems Excerpt :

The metabolic regulation of a cell system is of critical importance in systems biology, and a robust model of these mechanisms is essential in predicting the effects on the metabolism of both the culture environment and the knockout of specific genes. Bacterial cellular metabolic systems focuses on this highly topical subject in relation to culture environment and provides a detailed analysis from gene level to metabolic level regulation, as well as offering a discussion of the most recent modelling approaches. The book begins with an introduction to metabolic mechanisms and to the metabolic regulation of a cell, before moving on to discussing the action of global regulators in response to a specific culture environment. The second half of the book examines conventional flux balance analysis and its applications, 13C-metabolic flux analysis, and the effect of a specific gene knockout on the metabolism. Comprehensive account of metabolic regulation via global regulators in response to changes in the culture environment Basic formulation of 13C-metabolic flux analysis based on 13C-labelling experiments Systems biology approach for the modelling and computer simulation of the main metabolic pathways of a cell system

Nanoparticulate Drug Delivery Book

Nanoparticulate Drug Delivery


  • Author : Vandana Patravale
  • Publisher : Elsevier
  • Release Date : 2012-10-31
  • Genre: Medical
  • Pages : 244
  • ISBN 10 : 9781908818195

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Nanoparticulate Drug Delivery 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