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Biopharmaceutical Processing

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Biopharmaceutical Processing

Biopharmaceutical Processing Book
Author : Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher
Publisher : Elsevier
Release : 2018-01-18
ISBN : 0128125527
Language : En, Es, Fr & De

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Book Description :

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

Advanced Technologies in Biopharmaceutical Processing

Advanced Technologies in Biopharmaceutical Processing Book
Author : Roshni Dutton,Jeno Scharer
Publisher : Wiley-Blackwell
Release : 2006-10-30
ISBN : 9780813805177
Language : En, Es, Fr & De

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Book Description :

An increasing number of pharmaceuticals in human and veterinary medicine are being developed using advanced genetic and other methods that focus on modification of somatic and embryonic cells. These methods, in the setting of drug manufacture, call for new processes that go beyond the traditional unit processes of chemical and biological production, such as batch submerged culture. This book is the first to describe in detail these advanced biological processes and show how they are applied to the production of biopharmaceuticals, from product generation and purification to fill-finish operations. The work explains how technologies developed in the last decade function similarly to unit operations for producing advanced biopharmaceuticals, such as hormones, cytokines, therapeutic enzymes, modified proteins, and transgenic products - to name a few. From large-scale animal cell bioreactors to patient-customized products, this volume describes the effects of new technologies on biopharmaceutical processes and guides users on how to apply new technologies in process development.

Biotechnology and Biopharmaceutical Manufacturing Processing and Preservation

Biotechnology and Biopharmaceutical Manufacturing  Processing  and Preservation Book
Author : Kenneth E. Avis,Vincent L. Wu
Publisher : CRC Press
Release : 2020-08-13
ISBN : 1000122948
Language : En, Es, Fr & De

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Book Description :

In this unique book, experts describe practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, the book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques. Large-scale chromatography for the purification of biomolecules in manufacturing and lyophilization of protein pharmaceuticals are discussed. Includes a case study on blow-fill-seal processing technology and a chapter on economic and cost factors for bioprocess engineering.

Filtration and Purification in the Biopharmaceutical Industry Third Edition

Filtration and Purification in the Biopharmaceutical Industry  Third Edition Book
Author : Maik W. Jornitz
Publisher : CRC Press
Release : 2019-06-26
ISBN : 1351675699
Language : En, Es, Fr & De

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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.

Biopharmaceutical Processing and Process Development

Biopharmaceutical Processing and Process Development   Book
Author : Vincent Michael O'Shaughnessy
Publisher : Unknown
Release : 2008
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Biopharmaceutical Processing and Process Development book written by Vincent Michael O'Shaughnessy, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

PAT Applied in Biopharmaceutical Process Development And Manufacturing

PAT Applied in Biopharmaceutical Process Development And Manufacturing Book
Author : Cenk Undey,Duncan Low,Jose C. Menezes,Mel Koch
Publisher : CRC Press
Release : 2011-12-07
ISBN : 1439829462
Language : En, Es, Fr & De

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Book Description :

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 comp

Process Scale Bioseparations for the Biopharmaceutical Industry

Process Scale Bioseparations for the Biopharmaceutical Industry Book
Author : Abhinav A. Shukla,Mark R. Etzel,Shishir Gadam
Publisher : CRC Press
Release : 2006-07-07
ISBN : 1420016024
Language : En, Es, Fr & De

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Book Description :

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 biopharmaceutical developers. Process Scale Bioseparations for the Biopharmaceutical Industry brings together scientific principles, empirical approaches, and practical considerations for designing industrial downstream bioprocesses for various classes of biomolecules. Using clear language along with numerous case studies, examples, tables, flow charts, and schematics, the book presents perspectives from experienced professionals involved in purification processes and industrial downstream unit operations. The authors provide useful experimental design strategies and guidelines for developing application-specific process scale bioseparations. Chapter topics include harvest by centrifugation and filtration, expanded bed chromatography, protein refolding, modes of preparative chromatography, methodologies for resin screening, membrane chromatography, protein crystallization, viral filtration, ultrafiltration/diafiltration, implementing post-approval downstream process changes for an antibody product, and future trends. Ideal for both new and experienced scientists in the biopharmaceutical industry and students, Process Scale Bioseparations for the Biopharmaceutical Industry is a comprehensive resource for all topics relevant to industrial process development.

Continuous Processing in Pharmaceutical Manufacturing

Continuous Processing in Pharmaceutical Manufacturing Book
Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
Release : 2015-02-09
ISBN : 3527335951
Language : En, Es, Fr & De

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Book Description :

With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Filtration and Purification in the Biopharmaceutical Industry

Filtration and Purification in the Biopharmaceutical Industry Book
Author : Maik W. Jornitz
Publisher : Unknown
Release : 2019
ISBN : 9781138056749
Language : En, Es, Fr & De

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Book Description :

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 this field including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. An essential, comprehensive source for all professionals involved with filtration and purification practices and compliance, this text describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and buffer filtration.

Single Use Technology in Biopharmaceutical Manufacture

Single Use Technology in Biopharmaceutical Manufacture Book
Author : Regine Eibl,Dieter Eibl
Publisher : John Wiley & Sons
Release : 2019-07-18
ISBN : 1119477786
Language : En, Es, Fr & De

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Book Description :

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.

Biopharmaceuticals

Biopharmaceuticals Book
Author : Gary Walsh
Publisher : John Wiley & Sons
Release : 2013-04-29
ISBN : 1118687388
Language : En, Es, Fr & De

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Book Description :

The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology. This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.

Handbook of Downstream Processing

Handbook of Downstream Processing Book
Author : E. Goldberg
Publisher : Springer Science & Business Media
Release : 2012-12-06
ISBN : 9400915632
Language : En, Es, Fr & De

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Book Description :

The last two decades have seen a phenomenal growth of the field of genetic or biochemical engineering and have witnessed the development and ultimately marketing of a variety of products-typically through the manipulation and growth of different types of microorganisms, followed by the recovery and purification of the associated products. The engineers and biotechnologists who are involved in the full-scale process design of such facilities must be familiar with the variety of unit operations and equipment and the applicable regulatory requirements. This book describes current commercial practice and will be useful to those engineers working in this field in the design, construction and operation of pharmaceutical and biotechnology plants. It will be of help to the chemical or pharmaceutical engineer who is developing a plant design and who faces issues such as: Should the process be batch or continuous or a combination of batch and continuous? How should the optimum process design be developed? Should one employ a new revolutionary separation which could be potentially difficult to validate or use accepted technology which involves less risk? Should the process be run with ingredients formulated from water for injection, deionized water, or even filtered tap water? Should any of the separations be run in cold rooms or in glycol jacketed lines to minimize microbial growth where sterilization is not possible? Should the process equipment and lines be designed to be sterilized in-place, cleaned-in-place, or should every piece be broken down, cleaned and autoclaved after every turn?

Magnetically Enhanced Centrifugation for Continuous Biopharmaceutical Processing

Magnetically Enhanced Centrifugation for Continuous Biopharmaceutical Processing Book
Author : Fei Chen (Ph. D.),Massachusetts Institute of Technology. Department of Chemical Engineering
Publisher : Unknown
Release : 2009
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

(cont.) DEM simulations were able to predict the three dimensional effects, including the buildup profiles at the wire tip. Taken together, the results of this work provide a general strategy that can be used as a starting point for the design, evaluation, and optimization of magnetically enhanced processes that are suitable for biopharmaceutical downstream processing.

Biopharmaceutical Manufacturing

Biopharmaceutical Manufacturing Book
Author : Gary Gilleskie,Charles Rutter,Becky McCuen
Publisher : Walter de Gruyter GmbH & Co KG
Release : 2021-09-07
ISBN : 3110616882
Language : En, Es, Fr & De

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Book Description :

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:

Filtration and Purification in the Biopharmaceutical Industry

Filtration and Purification in the Biopharmaceutical Industry Book
Author : Maik J. Jornitz,Maik W. Jornitz,Theodore H. Meltzer
Publisher : CRC Press
Release : 2007-11-28
ISBN : 0849379547
Language : En, Es, Fr & De

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Book Description :

Filtration and Purification in the Biopharmaceutical Industry, First Edition greatly expands its focus with extensive new material on the critical role of purification and the significant advances in filtration science and technology. This new edition provides state-of-the-science information on all aspects of filtration and purification, in

Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts

Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts Book
Author : Claire Komives,Weichang Zhou
Publisher : John Wiley & Sons
Release : 2018-12-27
ISBN : 1118361989
Language : En, Es, Fr & De

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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

Biopharmaceutical Production Technology

Biopharmaceutical Production Technology Book
Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
Release : 2012-05-14
ISBN : 3527653112
Language : En, Es, Fr & De

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Book Description :

Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes. This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals. It is divided into seven major parts: - Upstream Technologies - Protein Recovery - Advances in Process Development - Analytical Technologies - Quality Control - Process Design and Management - Changing Face of Processing With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.

Disposable Bioprocessing Systems

Disposable Bioprocessing Systems Book
Author : Sarfaraz K. Niazi
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1000218740
Language : En, Es, Fr & De

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Book Description :

Written by a researcher with experience designing, establishing, and validating biological manufacturing facilities worldwide, this is the first comprehensive introduction to disposable systems for biological drug manufacturing. It reviews the current state of the industry; tackles questions about safety, costs, regulations, and waste disposal; and guides readers to choose disposable components that meet their needs. This practical manual covers disposable containers, mixing systems, bioreactors, connectors and transfers, controls and sensors, downstream processing systems, filling and finishing systems, and filters. The author also shares his predictions for the future, calling disposable bioprocessing technology a "game changer."

Bioprocessing for Cell Based Therapies

Bioprocessing for Cell Based Therapies Book
Author : Che J. Connon
Publisher : John Wiley & Sons
Release : 2017-02-06
ISBN : 1118743415
Language : En, Es, Fr & De

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Book Description :

With contributions from leading, international academics and industrial practitioners, Bioprocessing for Cell-Based Therapies explores the very latest techniques and guidelines in bioprocess production to meet safety, regulatory and ethical requirements, for the production of therapeutic cells, including stem cells. An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout In depth discussion of the application of cell therapy including methods used in the delivery of cells to the patient Includes contributions from experts in both academia and industry, combining a practical approach with cutting edge research The only handbook currently available to provide a state of the art guide to Bioprocessing covering the complete range of cell-based therapies, from experts in academia and industry

Handbook of Validation in Pharmaceutical Processes Fourth Edition

Handbook of Validation in Pharmaceutical Processes  Fourth Edition Book
Author : James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
Publisher : CRC Press
Release : 2021-10-29
ISBN : 1000436012
Language : En, Es, Fr & De

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Book Description :

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture