Biopharmaceutical 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 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

Produk Detail:

  • Author : Gunter Jagschies
  • Publisher : Elsevier
  • Pages : 1308 pages
  • ISBN : 0128125527
  • Rating : 5/5 from 1 reviews
CLICK HERE TO GET THIS BOOKBiopharmaceutical Processing

Biopharmaceutical Processing

Biopharmaceutical Processing
  • Author : Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher
  • Publisher : Elsevier
  • Release : 18 January 2018
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

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 : 07 December 2011
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 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

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 : 07 December 2011
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

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 : 13 August 2020
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.

Single-Use Technology in Biopharmaceutical Manufacture

Single-Use Technology in Biopharmaceutical Manufacture
  • Author : Regine Eibl,Dieter Eibl
  • Publisher : John Wiley & Sons
  • Release : 08 August 2011
GET THIS BOOKSingle-Use Technology in Biopharmaceutical Manufacture

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.

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 : 07 July 2006
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,

Biopharmaceutical Manufacturing

Biopharmaceutical Manufacturing
  • Author : Gary Gilleskie,Charles Rutter,Becky McCuen
  • Publisher : Walter de Gruyter GmbH & Co KG
  • Release : 07 September 2021
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

Biopharmaceutical Production Technology

Biopharmaceutical Production Technology
  • Author : Ganapathy Subramanian
  • Publisher : John Wiley & Sons
  • Release : 14 May 2012
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

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 : 13 July 2010
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

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 : 09 May 2012
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

Handbook of Downstream Processing

Handbook of Downstream Processing
  • Author : E. Goldberg
  • Publisher : Springer Science & Business Media
  • Release : 06 December 2012
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

Biopharmaceuticals

Biopharmaceuticals
  • Author : Gary Walsh
  • Publisher : John Wiley & Sons
  • Release : 29 April 2013
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

Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Handbook of Validation in Pharmaceutical Processes, Fourth Edition
  • Author : James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
  • Publisher : CRC Press
  • Release : 28 October 2021
GET THIS BOOKHandbook of Validation in Pharmaceutical Processes, Fourth Edition

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

New and Future Developments in Microbial Biotechnology and Bioengineering

New and Future Developments in Microbial Biotechnology and Bioengineering
  • Author : Alexandre Gomes Rodrigues
  • Publisher : Elsevier
  • Release : 10 June 2020
GET THIS BOOKNew and Future Developments in Microbial Biotechnology and Bioengineering

New and Future Developments in Microbial Biotechnology and Bioengineering: Microbial Biomolecules: Properties, Relevance and Their Translational Applications presents a concise review on microbial biotechnology, along with impacts and recent results from research centers, small companies and large enterprises. The book brings the most relevant information on how we can use resources—in this case from microorganisms—and technology to develop solutions in fields like biofuels, food, cosmetics and medicine. It covers case studies of start-ups in the field and explains

Biotechnology

Biotechnology
  • Author : Kenneth E. Avis,Carmen M. Wagner,Vincent L. Wu
  • Publisher : CRC Press
  • Release : 22 April 2020
GET THIS BOOKBiotechnology

Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a