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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

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.

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

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?

Biopharmaceuticals

Biopharmaceuticals Book
Author : Gary Walsh
Publisher : Wiley
Release : 1998-06-18
ISBN : 9780471977889
Language : En, Es, Fr & De

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Book Description :

Biopharmaceuticals: Biochemistry and Biotechnology provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Specific chapters detail therapeutic substances such as interferons, interleukins and growth factors, as well as hormones, therapeutic enzymes, blood products, antibodies, and vaccines. While the emphasis is placed upon polypeptide-based therapeutic agents, the potential applications of nucleic acids with regard to gene therapy and antisense technology are considered in the final chapter. In addition, other chapters detail regulatory issues as applied to biopharmaceuticals, and how such products are manufactured in practice. The author has produced an up-to-date, easy-to-read book and each chapter is supplemented with a substantial further reading section. It is of particular relevance to students undertaking advanced undergraduate or postgraduate courses in biotechnology, biochemistry, pharmaceutical science or medicine. Its scope also renders it an ideal reference for those already employed in the (bio)pharmaceutical sector who wish to gain a better overview of the industry in which they work.

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 : 9780849379543
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

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.

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.

Single Use Technology in Biopharmaceutical Manufacture

Single Use Technology in Biopharmaceutical Manufacture Book
Author : Regine Eibl,Dieter Eibl
Publisher : John Wiley & Sons
Release : 2011-08-08
ISBN : 0470922761
Language : En, Es, Fr & De

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Book Description :

This book gives an overview of commonly-used disposables in the manufacture of biopharmaceuticals, their working principles, characteristics, engineering aspects, economics, and applications. With this information, readers will be able to come to an easier decision for or against disposable alternatives and to choose the appropriate system. The book is divided into two parts – the first is related to basic knowledge about disposable equipment; and the second discusses applications through case studies that illustrate manufacturing, quality assurance, and environmental influence.

The Chemical Engineer

The Chemical Engineer Book
Author : Anonim
Publisher : Unknown
Release : 2008
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download The Chemical Engineer book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

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.

Quality by Design for Biopharmaceuticals

Quality by Design for Biopharmaceuticals Book
Author : Anurag S. Rathore,Rohin Mhatre
Publisher : John Wiley & Sons
Release : 2011-09-20
ISBN : 1118210913
Language : En, Es, Fr & De

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Book Description :

The concepts, applications, and practical issues of Quality byDesign Quality by Design (QbD) is a new framework currently beingimplemented by the FDA, as well as EU and Japanese regulatoryagencies, to ensure better understanding of the process so as toyield a consistent and high-quality pharmaceutical product. QbDbreaks from past approaches in assuming that drug quality cannot betested into products; rather, it must be built into every step ofthe product creation process. Quality by Design: Perspectives and Case Studies presentsthe first systematic approach to QbD in the biotech industry. Acomprehensive resource, it combines an in-depth explanation ofbasic concepts with real-life case studies that illustrate thepractical aspects of QbD implementation. In this single source, leading authorities from thebiotechnology industry and the FDA discuss such topics as: The understanding and development of the product's criticalquality attributes (CQA) Development of the design space for a manufacturingprocess How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates toQbD Relevant PAT tools and applications for the pharmaceuticalindustry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) toQbD Filled with vivid case studies that illustrate QbD at work incompanies today, Quality by Design is a core reference forscientists in the biopharmaceutical industry, regulatory agencies,and students.

Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products

Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products Book
Author : Fred Brown,Anthony S. Lubiniecki
Publisher : S Karger Ag
Release : 1996
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Assurance that biopharmaceuticals do not contain unwanted infectious agents is a vital safety consideration in the use of these products. This can only be ensured by careful screening of the cells and other materials used in their production, and subsequent testing of the final product. This publication reports the proceedings of an international conference which focused on the methods of how to avoid contamination of cell cultures with virus during the production process of biologicals, with the aim of providing harmonized guidelines to ensure product safety. Scientists from industry and regulatory agencies present updates on the current state of knowledge about assays for viral contamination and procedures for inactivation and removal. Risks associated with the processing of biopharmaceuticals are identified, and data on the actual experiences of testing and industrial laboratories are presented and discussed in the context of the clinical setting. Drawing together a wealth of new data, this book will be essential reading for all scientists concerned with the development, production and quality control of biopharmaceutical products.

Protein Chromatography

Protein Chromatography Book
Author : Giorgio Carta,Alois Jungbauer
Publisher : John Wiley & Sons
Release : 2010-06-15
ISBN : 3527318194
Language : En, Es, Fr & De

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Book Description :

With its focus on process development and large-scale bioseparation tasks, this is tailor-made reading for the professional bioengineer in both the biotech and pharmaceutical industries. Following a tried-and-tested concept, this guide has been developed over several years in training courses for biotech and chemical engineers in Europe and the U.S. The first part deals with the theory, introducing chromatography and its dynamics, as well as discussing mass transfer and dispersion effects. The second part then goes on to cover equipment and protocols, determining the retention factor and HETP from isocratic and elution experiments, as well as the mass transfer and intraparticle diffusivity from batch and shallow-bed adsorption experiments.

Centrifugal Separations in Biotechnology

Centrifugal Separations in Biotechnology Book
Author : Wallace Woon-Fong Leung
Publisher : Elsevier
Release : 2007-08-16
ISBN : 0080549721
Language : En, Es, Fr & De

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Book Description :

This book is the first devoted to centrifugal separation in biotechnology. It is of value to professionals in the chemical, bioprocess, and biotech sectors, and all those concerned with bioseparation, bioprocessing, unit-operations and process engineering. Key topics covered include a full introduction to centrifugation, sedimentation and separation; detailed coverage of centrifuge types, including batch and semi-batch centrifuges, disk-stack and tubular decanter centrifuges; methods for increasing solids concentration; laboratory and pilot testing of centrifuges; selection and sizing centrifuges; scale-up of equipment, performance prediction and analysis of test results using numerical simulation. A comprehensive guide to centrifuges, their optimal development and operation in the biotechnology industry Applications for the separation of proteins, DNA, mitochondria, ribosomes, lysosomes and other cellular elements Provides detailed process information and data to assist in the development of particular processes from existing systems Explores the commercial applications of centrifuges in biotechnology Guidance on troubleshooting and optimizing centrifuges

Chemical Engineering Progress

Chemical Engineering Progress Book
Author : Anonim
Publisher : Unknown
Release : 2009
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Chemical Engineering Progress book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Handbook of Pharmaceutical Biotechnology

Handbook of Pharmaceutical Biotechnology Book
Author : Shayne C. Gad
Publisher : Wiley-Interscience
Release : 2007-06-11
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Describes the use of biotechnology to develop pharmaceuticals. This book gives the professional a basic tool to facilitate the development of biotech medicines by bringing together a general overview of biotechnology used in the drug development process, along with a compendium of regulations and validation methods.

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.

Pharmaceutical Biotechnology

Pharmaceutical Biotechnology Book
Author : Gary Walsh
Publisher : John Wiley & Sons
Release : 2013-04-25
ISBN : 111868575X
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific ‘product category chapters’ focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

Monitoring of Product Variants in Biopharmaceutical Downstream Processing

Monitoring of Product Variants in Biopharmaceutical Downstream Processing Book
Author : Patricia Roch
Publisher : Unknown
Release : 2019
ISBN : 9789176850022
Language : En, Es, Fr & De

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Book Description :

Download Monitoring of Product Variants in Biopharmaceutical Downstream Processing book written by Patricia Roch, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.