Biopharmaceutical Processing

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  • Publisher : Elsevier
  • Release : 18 January 2018
  • ISBN : 9780128125526
  • Page : 1308 pages
  • Rating : 5/5 from 1 voters

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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

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Biopharmaceutical Processing

Biopharmaceutical Processing
  • Author : Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher
  • Publisher : Elsevier
  • Release Date : 2018-01-18
  • ISBN : 9780128125526
GET THIS BOOKBiopharmaceutical Processing

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

Biopharmaceutical Manufacturing

Biopharmaceutical Manufacturing
  • Author : Gary Gilleskie,Charles Rutter,Becky McCuen
  • Publisher : Walter de Gruyter GmbH & Co KG
  • Release Date : 2021-09-06
  • ISBN : 9783110617016
GET THIS BOOKBiopharmaceutical Manufacturing

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

Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation

Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation
  • Author : Kenneth E. Avis,Vincent L. Wu
  • Publisher : CRC Press
  • Release Date : 2020-08-13
  • ISBN : 9781000122947
GET THIS BOOKBiotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation

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.

Process Scale Bioseparations for the Biopharmaceutical Industry

Process Scale Bioseparations for the Biopharmaceutical Industry
  • Author : Abhinav A. Shukla,Mark R. Etzel,Shishir Gadam
  • Publisher : CRC Press
  • Release Date : 2006-07-07
  • ISBN : 9781420016024
GET THIS BOOKProcess Scale Bioseparations for the Biopharmaceutical Industry

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,

Single-Use Technology in Biopharmaceutical Manufacture

Single-Use Technology in Biopharmaceutical Manufacture
  • Author : Regine Eibl,Dieter Eibl
  • Publisher : John Wiley & Sons
  • Release Date : 2019-07-18
  • ISBN : 9781119477785
GET THIS BOOKSingle-Use Technology in Biopharmaceutical Manufacture

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

Biopharmaceutical Production Technology

Biopharmaceutical Production Technology
  • Author : Ganapathy Subramanian
  • Publisher : John Wiley & Sons
  • Release Date : 2012-05-14
  • ISBN : 9783527653119
GET THIS BOOKBiopharmaceutical Production Technology

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

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition
  • Author : Anurag S. Rathore,Gail Sofer
  • Publisher : CRC Press
  • Release Date : 2012-05-09
  • ISBN : 9781439850930
GET THIS BOOKProcess Validation in Manufacturing of Biopharmaceuticals, Third Edition

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 final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of

PAT Applied in Biopharmaceutical Process Development And Manufacturing

PAT Applied in Biopharmaceutical Process Development And Manufacturing
  • Author : Cenk Undey,Duncan Low,Jose C. Menezes,Mel Koch
  • Publisher : CRC Press
  • Release Date : 2011-12-07
  • ISBN : 9781439829462
GET THIS BOOKPAT Applied in Biopharmaceutical Process Development And Manufacturing

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

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
  • Author : Feroz Jameel,Susan Hershenson
  • Publisher : John Wiley & Sons
  • Release Date : 2010-07-13
  • ISBN : 9780470595879
GET THIS BOOKFormulation and Process Development Strategies for Manufacturing Biopharmaceuticals

A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on

Freeze-drying of Pharmaceuticals and Biopharmaceuticals

Freeze-drying of Pharmaceuticals and Biopharmaceuticals
  • Author : Felix Franks,Tony Auffret
  • Publisher : Royal Society of Chemistry
  • Release Date : 2008
  • ISBN : 9780854041510
GET THIS BOOKFreeze-drying of Pharmaceuticals and Biopharmaceuticals

Aimed at product and process developers in the biopharmaceutical industry and academia, this is the first book to describe freeze-drying, as related to the pharmaceutical industry.

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
  • Author : John Geigert
  • Publisher : Springer Science & Business Media
  • Release Date : 2012-12-06
  • ISBN : 9781441991317
GET THIS BOOKThe Challenge of CMC Regulatory Compliance for Biopharmaceuticals

"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would

Biopharmaceutical Manufacturing

Biopharmaceutical Manufacturing
  • Author : Gary Gilleskie,Charles Rutter,Becky McCuen
  • Publisher : Walter de Gruyter GmbH & Co KG
  • Release Date : 2021-09-07
  • ISBN : 9783110616880
GET THIS BOOKBiopharmaceutical Manufacturing

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

Handbook of Downstream Processing

Handbook of Downstream Processing
  • Author : E. Goldberg
  • Publisher : Springer Science & Business Media
  • Release Date : 2012-12-06
  • ISBN : 9789400915633
GET THIS BOOKHandbook of Downstream Processing

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

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing
  • Author : Hamid Mollah,Mike Long,Harold Baseman
  • Publisher : John Wiley & Sons
  • Release Date : 2013-03-18
  • ISBN : 9780470552346
GET THIS BOOKRisk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

This book contains both the theory and practice of risk management (RM) and provides the background, tools, and application of risk in pharmaceutical and biologics manufacturing and operations. It includes case studies and specific examples of use of RM for biological and pharmaceutical product manufacture. The book also includes useful references and a bibliography for the reader who wishes to gain additional knowledge in the subject. It aids in assisting both industry and regulatory agencies to implement compliant and effective

Biopharmaceuticals

Biopharmaceuticals
  • Author : Gary Walsh
  • Publisher : John Wiley & Sons
  • Release Date : 2013-04-29
  • ISBN : 9781118687383
GET THIS BOOKBiopharmaceuticals

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