Monoclonal Antibodies

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  • Publisher : Woodhead Publishing
  • Release : 24 April 2015
  • ISBN : 9780081002971
  • Page : 224 pages
  • Rating : 4.5/5 from 103 voters

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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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Monoclonal Antibodies

Monoclonal Antibodies
  • Author : Steven Shire
  • Publisher : Woodhead Publishing
  • Release Date : 2015-04-24
  • ISBN : 9780081002971
GET THIS BOOKMonoclonal Antibodies

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

Formulation of Monoclonal Antibody Therapies

Formulation of Monoclonal Antibody Therapies
  • Author : Amal Ali Elkordy
  • Publisher : Academic Press
  • Release Date : 2021-10-15
  • ISBN : 0128233656
GET THIS BOOKFormulation of Monoclonal Antibody Therapies

Formulation of Monoclonal Antibody Therapies: From Lab to Market covers a wide range of topics about therapeutic monoclonal antibodies (mAbs) with a focus on formulation aspects. Therapeutic monoclonal antibodies are used for treatment of chronic diseases. It brings together a comprehensive knowledge in one accessible volume. Starting with foundational information on monoclonal antibodies, the book then discusses the importance of biopharmaceutical products, monoclonal antibodies and biosimilars in treatment of chronic diseases, pharmaceutical aspects of mAbs, and how it can be

Development of Biopharmaceutical Drug-Device Products

Development of Biopharmaceutical Drug-Device Products
  • Author : Feroz Jameel,John W. Skoug,Robert R. Nesbitt
  • Publisher : Springer Nature
  • Release Date : 2020-03-13
  • ISBN : 9783030314156
GET THIS BOOKDevelopment of Biopharmaceutical Drug-Device Products

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and

Monoclonal Antibody Production

Monoclonal Antibody Production
  • Author : National Research Council,Institute for Laboratory Animal Research,Committee on Methods of Producing Monoclonal Antibodies
  • Publisher : National Academies Press
  • Release Date : 1999-06-06
  • ISBN : 9780309064477
GET THIS BOOKMonoclonal Antibody Production

The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of Health (NIH) on April 23, 1997, to prohibit the use of animals in the production of mAb. On September 18, 1997, NIH declined to prohibit the use of mice in mAb production, stating that "the ascites method of mAb production is scientifically appropriate for some research projects and cannot be replaced." On March 26, 1998, AAVS submitted a second petition, stating that "NIH failed to provide valid scientific reasons for not supporting a proposed ban." The

Therapeutic Monoclonal Antibodies

Therapeutic Monoclonal Antibodies
  • Author : Zhiqiang An
  • Publisher : John Wiley & Sons
  • Release Date : 2011-09-20
  • ISBN : 9781118210260
GET THIS BOOKTherapeutic Monoclonal Antibodies

70-chapter authoritative reference that covers therapeutic monoclonal antibody discovery, development, and clinical applications while incorporating principles, experimental data, and methodologies. First book to address the discovery and development of antibody therapeutics in their entirety. Most chapters contain experimental data to illustrate the principles described in them. Authors provide detailed methodologies that readers can take away with them and use in their own laboratories.

Bioconjugate Techniques

Bioconjugate Techniques
  • Author : Greg T. Hermanson
  • Publisher : Academic Press
  • Release Date : 2013-07-25
  • ISBN : 9780123822406
GET THIS BOOKBioconjugate Techniques

Bioconjugate Techniques, 3rd Edition, is the essential guide to the modification and cross linking of biomolecules for use in research, diagnostics, and therapeutics. It provides highly detailed information on the chemistry, reagent systems, and practical applications for creating labeled or conjugate molecules. It also describes dozens of reactions, with details on hundreds of commercially available reagents and the use of these reagents for modifying or crosslinking peptides and proteins, sugars and polysaccharides, nucleic acids and oligonucleotides, lipids, and synthetic polymers.

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition
  • Author : Lars Hovgaard,Sven Frokjaer,Marco van de Weert
  • Publisher : CRC Press
  • Release Date : 2012-11-14
  • ISBN : 9781439853887
GET THIS BOOKPharmaceutical Formulation Development of Peptides and Proteins, Second Edition

The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product. Providing integrated solutions, this book discusses: The synthesis of peptides and the

Current Trends in Monoclonal Antibody Development and Manufacturing

Current Trends in Monoclonal Antibody Development and Manufacturing
  • Author : Steven J. Shire,Wayne Gombotz,Karoline Bechtold-Peters,James Andya
  • Publisher : Springer Science & Business Media
  • Release Date : 2009-11-11
  • ISBN : 038776643X
GET THIS BOOKCurrent Trends in Monoclonal Antibody Development and Manufacturing

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

Antibody Drug Discovery

Antibody Drug Discovery
  • Author : Clive R. Wood
  • Publisher : World Scientific
  • Release Date : 2012
  • ISBN : 9781848166288
GET THIS BOOKAntibody Drug Discovery

Antibody-based therapeutics are a central driver of the success of biopharmaceuticals. The discovery technology of this field is isolated to a limited number of centers of excellence in industry and academia. The objective of this volume is to provide a series of guides to those evaluating and preparing to enter particular areas within the field. Each chapter is written with a historical perspective that sets into context the significance of the key developments, and with the provision of “points to

From Clone to Clinic

From Clone to Clinic
  • Author : Daan J.A. Crommelin,H. Schellekens
  • Publisher : Springer Science & Business Media
  • Release Date : 2012-12-06
  • ISBN : 9789401137805
GET THIS BOOKFrom Clone to Clinic

This book contains a selection of the papers presented at the meeting "Between Clone and Clinic" which was organised in March 1990 in Amsterdam by the dutch Organisation for Applied Research, TNO, and the University of Utrecht. The scope of this meeting was the development of biotechnological pharmaceuticals mainly made by recombinant DNA technology or monoclonal antibody techniques. All aspects concerning the development of the products after host cells producing them are obtained where discussed. The meeting was attended by twohundred

Process Scale Purification of Antibodies

Process Scale Purification of Antibodies
  • Author : Uwe Gottschalk
  • Publisher : John Wiley & Sons
  • Release Date : 2017-04-03
  • ISBN : 9781119126911
GET THIS BOOKProcess Scale Purification of Antibodies

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

Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies

Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies
  • Author : Manmohan Singh,Maya Salnikova
  • Publisher : Academic Press
  • Release Date : 2014-12-30
  • ISBN : 9780124166615
GET THIS BOOKNovel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies

Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies takes a look at the current strategies, successes and challenges involved with the development of novel formulations of biologics, vaccines and cancer therapy. This thorough reference on the latest trends in the development of diverse modalities will appeal to a broad community of scientists, students and clinicians. Written by leading authors across academia and industry, this book covers important topics such as unique drug delivery devices, non-parenteral delivery trends, novel

Therapeutic Antibody Engineering

Therapeutic Antibody Engineering
  • Author : William R Strohl,Lila M Strohl
  • Publisher : Elsevier
  • Release Date : 2012-10-16
  • ISBN : 9781908818096
GET THIS BOOKTherapeutic Antibody Engineering

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

Monoclonal Antibodies

Monoclonal Antibodies
  • Author : Lei Zheng
  • Publisher : Unknown
  • Release Date : 2014
  • ISBN : 1910419486
GET THIS BOOKMonoclonal Antibodies

This ebook provides a thorough overview of antibody therapy development, including antibody selection, formulation development, conjugation, dose determination, pharmacokinetics/pharmacodynamic, labelling for imaging, and more. Case studies of approved antibodies are included, along with a look ahead to the future by reviewing treatments in clinical development.

Immunologic Concepts in Transfusion Medicine

Immunologic Concepts in Transfusion Medicine
  • Author : Robert W Maitta
  • Publisher : Elsevier Health Sciences
  • Release Date : 2019-08-27
  • ISBN : 9780323675109
GET THIS BOOKImmunologic Concepts in Transfusion Medicine

Immunological Concepts in Transfusion Medicine provides a thorough discussion of the immune aspects of blood component transfusion, with in-depth information on the intricacies of immune responses to blood components and the immune processes that may be initiated in response to blood exposure. Written to increase knowledge and awareness of immune challenges such as alloimmunization and transfusion-related acute lung injury, this title bridges current basic scientific discoveries and the potential effects seen in blood recipients. Complies the knowledge and expertise of