Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry PDF Download
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Author: Kumar Gadamasetti
Publisher: Springer Nature
ISBN: 3031620070
Category :
Languages : en
Pages : 559
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Book Description
Author: Kumar Gadamasetti
Publisher: Springer Nature
ISBN: 3031620070
Category :
Languages : en
Pages : 559
Get Book Here
Book Description
Author: Kumar Gadamasetti
Publisher: Springer
ISBN: 9783031620065
Category : Technology & Engineering
Languages : en
Pages : 0
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Book Description
This book outlines how advances in the diverse scientific and engineering disciplines of synthetic biology, DNA synthesis, production of protein therapeutics, and bioinformatics have led to the commercialization of new complex biotherapeutic modalities in modern era, including monoclonal and multi-specific antibodies, antibody drug conjugates (ADC), fusion proteins, CAR-T and CRISPR technologies and applications, mRNA vaccines and more. Enabling operations to bring these life-changing medicines into the hands of the needy patients include regulatory submissions to authorities across the globe, as well as streamlined production across manufacturing networks deemed necessary and are outlined in dedicated chapters. Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry: Using Chemistry and Bioengineering to Improve the Performance of Biologics captures the state of the art for many of these new modalities, offering innovative approaches to treat, prevent, and in some providential cases, cure the disease. This book will be of significant interest for many disciplines engaged jointly as teams convergently in delivering these medicines: bioprocess engineers, biologists, chemists, bioengineers, genetic engineers, healthcare professionals, regulatory bodies, among pharmaceutical industry professionals as well as in academic circles.
Author: Nuala Calnan
Publisher: CRC Press
ISBN: 1315351366
Category : Medical
Languages : en
Pages : 357
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Book Description
This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.
Author: Claire Komives
Publisher: John Wiley & Sons
ISBN: 1118361989
Category : Science
Languages : en
Pages : 288
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Book Description
Written for industrial and academic researchers and development scientists in the life sciences industry, Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts is a guide to the tools, approaches, and useful developments in bioprocessing. This important guide: • Summarizes state-of-the-art bioprocessing methods and reviews applications in life science industries • Includes illustrative case studies that review six milestone bio-products • Discuses a wide selection of host strain types and disruptive bioprocess technologies
Author: Maik W. Jornitz
Publisher: CRC Press
ISBN: 1351675699
Category : Business & Economics
Languages : en
Pages : 673
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Book Description
Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.
Author: Gary Walsh
Publisher: John Wiley & Sons
ISBN: 111868575X
Category : Science
Languages : en
Pages : 499
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Book Description
Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific ‘product category chapters’ focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed
Author: Andrzej Gorak
Publisher: Royal Society of Chemistry
ISBN: 1788010329
Category : Science
Languages : en
Pages : 544
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Book Description
The first book dedicated entirely to this area, Intensification of Biobased Processes provides a comprehensive overview of modern process intensification technologies used in bioprocessing.
Author: Anurag S. Rathore
Publisher: John Wiley & Sons
ISBN: 1118210913
Category : Science
Languages : en
Pages : 279
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Book Description
The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.
Author: Michael C. Flickinger
Publisher: John Wiley & Sons
ISBN: 111861898X
Category : Science
Languages : en
Pages : 884
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Book Description
DOWNSTREAM INDUSTRIAL BIOTECHNOLOGY An affordable, easily accessible desk reference on biomanufacturing, focused on downstream recovery and purification Advances in the fundamental knowledge surrounding biotechnology, novel materials, and advanced engineering approaches continue to be translated into bioprocesses that bring new products to market at a significantly faster pace than most other industries. Industrial scale biotechnology and new manufacturing methods are revolutionizing medicine, environmental monitoring and remediation, consumer products, food production, agriculture, and forestry, and continue to be a major area of research. The downstream stage in industrial biotechnology refers to recovery, isolation, and purification of the microbial products from cell debris, processing medium and contaminating biomolecules from the upstream process into a finished product such as biopharmaceuticals and vaccines. Downstream process design has the greatest impact on overall biomanufacturing cost because not only does the biochemistry of different products ( e.g., peptides, proteins, hormones, antibiotics, and complex antigens) dictate different methods for the isolation and purification of these products, but contaminating byproducts can also reduce overall process yield, and may have serious consequences on clinical safety and efficacy. Therefore downstream separation scientists and engineers are continually seeking to eliminate, or combine, unit operations to minimize the number of process steps in order to maximize product recovery at a specified concentration and purity. Based on Wiley’s Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation, and Cell Technology, this volume features fifty articles that provide information on down- stream recovery of cells and protein capture; process development and facility design; equipment; PAT in downstream processes; downstream cGMP operations; and regulatory compliance. It covers: Cell wall disruption and lysis Cell recovery by centrifugation and filtration Large-scale protein chromatography Scale down of biopharmaceutical purification operations Lipopolysaccharide removal Porous media in biotechnology Equipment used in industrial protein purification Affinity chromatography Antibody purification, monoclonal and polyclonal Protein aggregation, precipitation and crystallization Freeze-drying of biopharmaceuticals Biopharmaceutical facility design and validation Pharmaceutical bioburden testing Regulatory requirements Ideal for graduate and advanced undergraduate courses on biomanufacturing, biochemical engineering, biopharmaceutical facility design, biochemistry, industrial microbiology, gene expression technology, and cell culture technology, Downstream Industrial Biotechnology is also a highly recommended resource for industry professionals and libraries.
Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527340637
Category : Science
Languages : en
Pages : 628
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Book Description
This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.
