Process Scale Bioseparations for the Biopharmaceutical Industry

Process Scale Bioseparations for the Biopharmaceutical Industry
Author: Abhinav A. Shukla
Publisher: CRC Press
Total Pages: 600
Release: 2006-07-07
Genre: Medical
ISBN: 1420016024

The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceut

Process Scale Purification of Antibodies

Process Scale Purification of Antibodies
Author: Uwe Gottschalk
Publisher: John Wiley & Sons
Total Pages: 849
Release: 2017-03-07
Genre: Medical
ISBN: 1119126932

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

Biopharmaceutical Processing

Biopharmaceutical Processing
Author: Gunter Jagschies
Publisher: Elsevier
Total Pages: 1310
Release: 2018-01-18
Genre: Technology & Engineering
ISBN: 0128125527

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

Antibody Expression and Production

Antibody Expression and Production
Author: Mohamed Al-Rubeai
Publisher: Springer Science & Business Media
Total Pages: 349
Release: 2011-05-16
Genre: Medical
ISBN: 940071257X

Engineered antibodies currently represent over 30% of biopharmaceuticals in clinical trials and their total worldwide sales continue to increase significantly. The importance of antibody applications is reflected in their increasing clinical and industrial applications as well as in the progression of established and emerging production strategies. This volume provides detailed coverage of the generation, optimization, characterization, production and applications of antibody. It provides the necessary theoretical background and description of methods for the expression of antibody in microbial and animal cell cultures and in transgenic animals and plants. There is a strong focus on those issues related to the production of intrabodies, bispecific antibody and antibody fragments and also to novel applications in cancer immunotherapy.

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.

A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry

A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry
Author: Nuala Calnan
Publisher: CRC Press
Total Pages: 357
Release: 2017-06-26
Genre: Medical
ISBN: 1315351366

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.

Process Validation in Manufacturing of Biopharmaceuticals

Process Validation in Manufacturing of Biopharmaceuticals
Author: Anurag S. Rathore
Publisher: CRC Press
Total Pages: 532
Release: 2012-05-09
Genre: Medical
ISBN: 1439850941

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in

PAT Applied in Biopharmaceutical Process Development And Manufacturing

PAT Applied in Biopharmaceutical Process Development And Manufacturing
Author: Cenk Undey
Publisher: CRC Press
Total Pages: 330
Release: 2011-12-07
Genre: Medical
ISBN: 1439829454

As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.

Single-Use Technology in Biopharmaceutical Manufacture

Single-Use Technology in Biopharmaceutical Manufacture
Author: Regine Eibl
Publisher: John Wiley & Sons
Total Pages: 368
Release: 2019-07-18
Genre: Medical
ISBN: 1119477786

Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.