Process Control Intensification And Digitalisation In Continuous Biomanufacturing
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Process Control Intensification And Digitalisation In Continuous Biomanufacturing
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Author : Ganapathy Subramanian
language : en
Publisher: John Wiley & Sons
Release Date : 2021-12-20
Process Control Intensification And Digitalisation In Continuous Biomanufacturing written by Ganapathy Subramanian and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-12-20 with Technology & Engineering categories.
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.
Bioprocess Intensification
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Author : Dirk Holtmann
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2024-07-01
Bioprocess Intensification written by Dirk Holtmann and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-07-01 with Science categories.
Application of Process Intensification (PI) presents a set of radically innovative principles in process and equipment design, which can bring significant benefits in terms of process efficiency, capital and operating expenses, quality, process safety, and sustainability. Typical approaches in bioprocess intensification are the reduction of the number of production steps, continuous processing, integrated processes, and alternative energy inputs.
Process Validation In Manufacturing Of Biopharmaceuticals
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Author : Anurag Singh Rathore
language : en
Publisher: CRC Press
Release Date : 2023-12-18
Process Validation In Manufacturing Of Biopharmaceuticals written by Anurag Singh Rathore and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-12-18 with Medical categories.
The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA. Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples. Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.
Continuous Pharmaceutical Processing And Process Analytical Technology
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Author : Ajit S. Narang
language : en
Publisher: CRC Press
Release Date : 2023-03-01
Continuous Pharmaceutical Processing And Process Analytical Technology written by Ajit S. Narang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03-01 with Medical categories.
Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why’ and the ‘how’, emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability. Features: Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugs Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized Addresses economic and practical considerations, unlike many other technical books Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies Highlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies
Biopharmaceutical Manufacturing
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Author : Ralf Pörtner
language : en
Publisher: Springer Nature
Release Date : 2024-01-10
Biopharmaceutical Manufacturing written by Ralf Pörtner and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-01-10 with Science categories.
This volume “Cell Engineerring 11 - Biopharmaceutical Manufacturing: Progress, Trends and Challenges” is a 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. The book comprises contributions of experts from academia and industry active in the field of cell culture development for the production of recombinant proteins, cell therapy and gene therapy, with consideration of Digital Twin ́s and facility design. The knowledge and expertise of the authors cover disciplines like cell biology, engineering, biotechnology and biomedical sciences. Inevitably, some omissions will occur in the test, but the authors have sought to avoid duplications by extensive cross-referencing to chapters in other volumes of this series and elsewhere. We hope the volume provides a useful compendium of techniques for scientists in industrial and research laboratories active in this field.
Biochemical Reaction Engineering
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Author : Kaustubha Mohanty
language : en
Publisher: CRC Press
Release Date : 2025-01-29
Biochemical Reaction Engineering written by Kaustubha Mohanty and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-01-29 with Technology & Engineering categories.
This textbook comprehensively covers fundamental and advanced aspects of biochemical engineering along with MATLAB codes. It comprehensively covers important topics including enzyme catalyzed reaction kinetics, catalytic antibodies and non-protein biomolecules as catalysts, process flow diagram (PFD), piping & instrumentation diagram (P&ID), wastewater treatment processes, design of fermenters and mass and energy balance. Pedagogical features including solved problems and unsolved exercises are interspersed throughout the text for better understanding. This book: Provides solid foundation and understanding of the fundamental principles of mathematics, science, and engineering Explores tools for solving theoretical and open-ended biochemical engineering problems Covers principles of downstream process and biochemical engineering principles with illustration and problems Discusses application of computer and programming in biochemical engineering Covers case studies for bioprocess plant design. The textbook is primarily written for senior undergraduate and graduate students in the fields of chemical engineering, biotechnology, and food process engineering for courses on biochemical engineering/bioprocess engineering/downstream processing.
Bioprocess And Analytics Development For Virus Based Advanced Therapeutics And Medicinal Products Atmps
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Author : Saurabh Gautam
language : en
Publisher: Springer Nature
Release Date : 2023-08-10
Bioprocess And Analytics Development For Virus Based Advanced Therapeutics And Medicinal Products Atmps written by Saurabh Gautam and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-08-10 with Medical categories.
This book reviews the knowledge, methods and available techniques in the rapidly advancing field of virus based vaccines and gene therapeutics. It also highlights new innovative tools and interdisciplinary techniques for bioprocess development and analytics of viruses and viral vectors. As such, it provides a timely and highly relevant resource, since current advances in pharmaceutical research have seen the rise of vaccines and advanced therapeutics and medicinal products (ATMPs), that rely on the power of viruses. However, developing bioprocesses and analytics required to create this often called “magic bullet” (i.e. gene therapy) remains an extremely challenging and costly task. This book offers strategies for overcoming hurdles and difficulties within in all the necessary steps of viral vector development - from scalability to purification methods and quality control. The book is intended for researchers working in academia or industry, as well as graduate students pursuing a career in virology.
Agricultural Biomass For The Synthesis Of Value Added Materials
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Author : Sankha Chakrabortty
language : en
Publisher: CRC Press
Release Date : 2024-09-30
Agricultural Biomass For The Synthesis Of Value Added Materials written by Sankha Chakrabortty and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-09-30 with Technology & Engineering categories.
This book is a comprehensive guide to bioconversion approaches based on microorganisms and enzymes for the valorization of underused wastes of diverse categories to produce new products. Optimized conditions for microbial and enzymatic valorization are discussed, along with related biotechnological considerations, environmental considerations, bioprocess development, obstacles, and future outlooks. Biofuels, bioenergy, and other platform chemicals are only some of the products that can be produced through this book's explanation of the microbiological processes involved in the bioconversion and valorization of wastes.
Continuous Manufacturing For The Modernization Of Pharmaceutical Production
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2019-04-05
Continuous Manufacturing For The Modernization Of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-05 with Medical categories.
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Continuous Biomanufacturing
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Author : Ganapathy Subramanian
language : en
Publisher: John Wiley & Sons
Release Date : 2017-09-12
Continuous Biomanufacturing written by Ganapathy Subramanian and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-12 with Science categories.
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.