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

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.

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

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

Single-Use Technology in Biopharmaceutical Manufacture

Single-Use Technology in Biopharmaceutical Manufacture
  • Author : Regine Eibl,Dieter Eibl
  • Publisher : John Wiley & Sons
  • Release : 24 July 2019
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

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,

Filtration and Purification in the Biopharmaceutical Industry, Third Edition

Filtration and Purification in the Biopharmaceutical Industry, Third Edition
  • Author : Maik W. Jornitz
  • Publisher : CRC Press
  • Release : 26 June 2019
GET THIS BOOKFiltration and Purification in the Biopharmaceutical Industry, Third Edition

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

Disposable Bioprocessing Systems

Disposable Bioprocessing Systems
  • Author : Sarfaraz K. Niazi
  • Publisher : CRC Press
  • Release : 19 April 2016
GET THIS BOOKDisposable Bioprocessing Systems

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

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

Biopharmaceuticals

Biopharmaceuticals
  • Author : Gary Walsh
  • Publisher : Wiley
  • Release : 18 June 1998
GET THIS BOOKBiopharmaceuticals

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

Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Biophysical Characterization of Proteins in Developing Biopharmaceuticals
  • Author : Damian J. Houde,Steven A. Berkowitz
  • Publisher : Elsevier
  • Release : 13 November 2019
GET THIS BOOKBiophysical Characterization of Proteins in Developing Biopharmaceuticals

Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today’s industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been

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 : 18 March 2013
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

Biotechnology

Biotechnology
  • Author : Kenneth E. Avis,Carmen M. Wagner,Vincent L. Wu
  • Publisher : CRC Press
  • Release : 31 October 1998
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

Modern Biopharmaceuticals

Modern Biopharmaceuticals
  • Author : Jörg Knäblein
  • Publisher : John Wiley & Sons
  • Release : 07 May 2013
GET THIS BOOKModern Biopharmaceuticals

This collection of high-profile contributions provides a unique insight into the development of novel, successful biopharmaceuticals. Outstanding authors, including Nobel laureate Robert Huber as well as prominent company researchers and CEOs, present valuable insider knowledge, limiting their scope to those procedures and developments with proven potential for the biotechnology industry. They cover all relevant aspects, from the establishment of biotechnology parks, the development of successful compounds and the implementation of efficient manufacturing processes, right up to the establishment of advanced

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 : 06 December 2012
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