Current Trends in Monoclonal Antibody Development and Manufacturing

2009-11-11 Medical

Author : Steven J. Shire
Release : 2009-11-11
Genre : Medical
Kind : eBook
Book Rating : 43X/5 ( reviews)

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Book Synopsis Current Trends in Monoclonal Antibody Development and Manufacturing by : Steven J. Shire

Download or read book Current Trends in Monoclonal Antibody Development and Manufacturing written by Steven J. Shire. This book was released on 2009-11-11. Available in PDF, EPUB and Kindle. Book excerpt: Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.

Antibodies

2013-03-07 Medical

Author : G. Subramanian
Release : 2013-03-07
Genre : Medical
Kind : eBook
Book Rating : 750/5 ( reviews)

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Book Synopsis Antibodies by : G. Subramanian

Download or read book Antibodies written by G. Subramanian. This book was released on 2013-03-07. Available in PDF, EPUB and Kindle. Book excerpt: If the antibody industry is to achieve its full potential in the next decade, the individual technical potentials must be exploited, the limitations must be addressed, and lessons learned must be applied both to current purification methods and to the new technologies that continue to emerge. This book presents an overview of the current advances applied in the manufacture of monoclonal antibody including: -concepts in development of manufacturing strategies, -importance of antibody fragments, -application of chromatography method development, -quality control, -effect of expression on antibody properties, -virus removal and safety, -pharmacokinetics, -regulatory aspects.

Therapeutic Antibody Engineering

2012-10-16 Medical

Author : William R Strohl
Release : 2012-10-16
Genre : Medical
Kind : eBook
Book Rating : 093/5 ( reviews)

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Book Synopsis Therapeutic Antibody Engineering by : William R Strohl

Download or read book Therapeutic Antibody Engineering written by William R Strohl. This book was released on 2012-10-16. Available in PDF, EPUB and Kindle. Book excerpt: The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. - Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships - Integration of knowledge across all areas of antibody engineering, development, and marketing - Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity

Process Scale Purification of Antibodies

2017-03-07 Medical

Author : Uwe Gottschalk
Release : 2017-03-07
Genre : Medical
Kind : eBook
Book Rating : 932/5 ( reviews)

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Book Synopsis Process Scale Purification of Antibodies by : Uwe Gottschalk

Download or read book Process Scale Purification of Antibodies written by Uwe Gottschalk. This book was released on 2017-03-07. Available in PDF, EPUB and Kindle. Book excerpt: Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing

Monoclonal Antibodies

2015-04-24 Medical

Author : Steven Shire
Release : 2015-04-24
Genre : Medical
Kind : eBook
Book Rating : 971/5 ( reviews)

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Book Synopsis Monoclonal Antibodies by : Steven Shire

Download or read book Monoclonal Antibodies written by Steven Shire. This book was released on 2015-04-24. Available in PDF, EPUB and Kindle. Book excerpt: Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent.This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophysical methods combined with genetic engineering is used to understand the solution properties of the formulation. The latter has become very important since many indications such as arthritis and asthma require the development of formulations for subcutaneous delivery (SC). The development of formulations for IV delivery is also important and comes with a different set of challenges. The challenges and strategies that can overcome these limitations are discussed in this book, starting with an introduction to these issues, followed by chapters detailing strategies to deal with them. Subsequent chapters explore the processing and storage of mAbs, development of delivery device technologies and conclude with a chapter on the future of mAbs in therapeutic remedies. - Discusses the challenges to develop MAbs for intravenous (IV) and subcutaneous delivery (SC) - Presents strategies to meet the challenges in development of MAbs for SC and IV administration - Discusses the use of biophysical analytical tools coupled with MAb engineering to understand what governs MAb properties at high concentration

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