Process Architecture in Biomanufacturing Facility Design

Process Architecture in Biomanufacturing Facility Design

Author: Jeffery Odum

Publisher: John Wiley & Sons

Published: 2018-01-26

Total Pages: 381

ISBN-13: 1118833651

DOWNLOAD EBOOK

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 approach Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.


Emerging Technologies in Manufacturing

Emerging Technologies in Manufacturing

Author: Matthew N. O. Sadiku

Publisher: Springer Nature

Published: 2023-03-15

Total Pages: 297

ISBN-13: 3031231562

DOWNLOAD EBOOK

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.


Biopharmaceutical Manufacturing

Biopharmaceutical Manufacturing

Author: Gary Gilleskie

Publisher: Walter de Gruyter GmbH & Co KG

Published: 2021-09-07

Total Pages: 347

ISBN-13: 3110616882

DOWNLOAD EBOOK

Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:


Sterile Product Facility Design and Project Management

Sterile Product Facility Design and Project Management

Author: Jeffrey N. Odum

Publisher: CRC Press

Published: 2004-03-29

Total Pages: 391

ISBN-13: 1420025856

DOWNLOAD EBOOK

Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provid


Biopharmaceutical Processing

Biopharmaceutical Processing

Author: Gunter Jagschies

Publisher: Elsevier

Published: 2018-01-18

Total Pages: 1310

ISBN-13: 0128125527

DOWNLOAD EBOOK

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. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. - Offers a comprehensive, go-to reference for daily work decisions - Covers both upstream and downstream processes - Includes case studies that emphasize financial outcomes - Presents summaries, decision grids, graphs and overviews for quick reference


Process Monitoring and Quality by Design for Biotechnology Products

Process Monitoring and Quality by Design for Biotechnology Products

Author: Neslihan Delacruz

Publisher: Morgan & Claypool Publishers

Published: 2010-12-31

Total Pages: 39

ISBN-13: 1615041141

DOWNLOAD EBOOK

Traditional pharmaceutical development is an unwieldy process requiring extensive experimentation and long lead times before process scientists can fully understand the effect that process parameters such as pH, temperature, cell viability, or process yield may have on the product acceptability. Implementation of quality by design is a science-based approach that allows the operating ranges and the acceptance criteria to be established based on the impact on product quality attributes. During manufacturing, process monitoring becomes part of a continuous verification effort and statistical control limits can be used to signal potential trends or drifts in the process. Single manufacturing batches that are aberrant are readily identified. The melding of scientific understanding, information systems architecture, instrumentation, software, and personnel training provides a large return on investment by ensuring that the manufacturing process produces a consistent pharmaceutical product that meets acceptable release standards for human use.


Biopharmaceutical Manufacturing

Biopharmaceutical Manufacturing

Author: Gary Gilleskie

Publisher: Walter de Gruyter GmbH & Co KG

Published: 2021-09-07

Total Pages: 433

ISBN-13: 3110617013

DOWNLOAD EBOOK

Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:


Continuous Biomanufacturing

Continuous Biomanufacturing

Author: Ganapathy Subramanian

Publisher: John Wiley & Sons

Published: 2017-12-26

Total Pages: 628

ISBN-13: 3527340637

DOWNLOAD EBOOK

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.