Continuous Biomanufacturing

Continuous Biomanufacturing
Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
Total Pages: 628
Release: 2017-12-26
Genre: Science
ISBN: 3527340637

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.

Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing

Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing
Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
Total Pages: 404
Release: 2021-12-20
Genre: Technology & Engineering
ISBN: 3527347690

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.

Continuous Manufacturing for the Modernization of Pharmaceutical Production

Continuous Manufacturing for the Modernization of Pharmaceutical Production
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 69
Release: 2019-04-05
Genre: Medical
ISBN: 0309487811

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

Continuous Biomanufacturing
Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
Total Pages: 697
Release: 2017-09-12
Genre: Science
ISBN: 3527699910

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.

Cell Culture Engineering

Cell Culture Engineering
Author: Gyun Min Lee
Publisher: John Wiley & Sons
Total Pages: 436
Release: 2020-01-13
Genre: Science
ISBN: 3527343342

Offers a comprehensive overview of cell culture engineering, providing insight into cell engineering, systems biology approaches and processing technology In Cell Culture Engineering: Recombinant Protein Production, editors Gyun Min Lee and Helene Faustrup Kildegaard assemble top class authors to present expert coverage of topics such as: cell line development for therapeutic protein production; development of a transient gene expression upstream platform; and CHO synthetic biology. They provide readers with everything they need to know about enhancing product and bioprocess attributes using genome-scale models of CHO metabolism; omics data and mammalian systems biotechnology; perfusion culture; and much more. This all-new, up-to-date reference covers all of the important aspects of cell culture engineering, including cell engineering, system biology approaches, and processing technology. It describes the challenges in cell line development and cell engineering, e.g. via gene editing tools like CRISPR/Cas9 and with the aim to engineer glycosylation patterns. Furthermore, it gives an overview about synthetic biology approaches applied to cell culture engineering and elaborates the use of CHO cells as common cell line for protein production. In addition, the book discusses the most important aspects of production processes, including cell culture media, batch, fed-batch, and perfusion processes as well as process analytical technology, quality by design, and scale down models. -Covers key elements of cell culture engineering applied to the production of recombinant proteins for therapeutic use -Focuses on mammalian and animal cells to help highlight synthetic and systems biology approaches to cell culture engineering, exemplified by the widely used CHO cell line -Part of the renowned "Advanced Biotechnology" book series Cell Culture Engineering: Recombinant Protein Production will appeal to biotechnologists, bioengineers, life scientists, chemical engineers, and PhD students in the life sciences.

Continuous Biopharmaceutical Processes

Continuous Biopharmaceutical Processes
Author: David Pfister
Publisher: Cambridge University Press
Total Pages: 349
Release: 2018-10-11
Genre: Medical
ISBN: 1108420222

Provides a coherent and critical view on the potential benefits of various continuous processes in the biopharmaceutical industry.

Solvay

Solvay
Author: Kenneth Bertrams
Publisher: Cambridge University Press
Total Pages: 649
Release: 2013-01-03
Genre: Business & Economics
ISBN: 1107311071

Ernest Solvay, philanthropist and organizer of the world-famous Solvay conferences on physics, discovered a profitable way of making soda ash in 1861. Together with a handful of associates, he laid the foundations of the Solvay company, which successfully branched out into other chemicals, plastics and pharmaceuticals. Since its emergence in 1863, Solvay has maintained world leadership in the production of soda ash. This is the first scholarly book on the history of the Solvay company, which was one of the earliest chemical multinationals and today is among the world's twenty largest chemical companies. It is also one of the largest companies in the field to preserve its family character. The authors analyze the company's 150-year history (1863–2013) from economic, political and social perspectives, showing the enormous impact geopolitical events had on the company and the recent consequences of global competition.

Cell Culture Engineering

Cell Culture Engineering
Author: Wei-Shu Hu
Publisher: Springer
Total Pages: 179
Release: 2006-08-16
Genre: Science
ISBN: 3540340076

Since the introduction of recombinant human growth hormone and insulin a quarter century ago, protein therapeutics has greatly broadened the ho- zon of health care. Many patients suffering with life-threatening diseases or chronic dysfunctions, which were medically untreatable not long ago, can attest to the wonder these drugs have achieved. Although the ?rst generation of p- tein therapeutics was produced in recombinant Escherichia coli, most recent products use mammalian cells as production hosts. Not long after the ?rst p- duction of recombinant proteins in E. coli, it was realized that the complex tasks of most post-translational modi?cations on proteins could only be ef?ciently carried out in mammalian cells. In the 1990s, we witnessed a rapid expansion of mammalian-cell-derived protein therapeutics, chie?y antibodies. In fact, it has been nearly a decade since the market value of mammalian-cell-derived protein therapeutics surpassed that of those produced from E. coli. A common characteristic of recent antibody products is the relatively large dose required for effective therapy, demanding larger quantities for the treatment of a given disease. This, coupled with the broadening repertoire of protein drugs, has rapidly expanded the quantity needed for clinical applications. The increasing demand for protein therapeutics has not been met exclusively by construction of new manufacturing plants and increasing total volume capacity. More - portantly the productivity of cell culture processes has been driven upward by an order of magnitude in the past decade.