Monoclonal 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 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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  • Author : Steven Shire
  • Publisher : Woodhead Publishing
  • Pages : 224 pages
  • ISBN : 0081002971
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKMonoclonal Antibodies

Monoclonal Antibodies

Monoclonal Antibodies
  • Author : Steven Shire
  • Publisher : Woodhead Publishing
  • Release : 24 April 2015
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 : 15 October 2021
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

Therapeutic Monoclonal Antibodies

Therapeutic Monoclonal Antibodies
  • Author : Zhiqiang An
  • Publisher : John Wiley & Sons
  • Release : 20 September 2011
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.

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 : 13 March 2020
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

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 : 11 November 2009
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

Fermentation Processes

Fermentation Processes
  • Author : Angela Jozala
  • Publisher : BoD – Books on Demand
  • Release : 08 February 2017
GET THIS BOOKFermentation Processes

Fermentation is a theme widely useful for food, feed and biofuel production. Indeed each of these areas, food industry, animal nutrition and energy production, has considerable presence in the global market. Fermentation process also has relevant applications on medical and pharmaceutical areas, such as antibiotics production. The present book, Fermentation Processes, reflects that wide value of fermentation in related areas. It holds a total of 14 chapters over diverse areas of fermentation research.

Challenges in Protein Product Development

Challenges in Protein Product Development
  • Author : Nicholas W. Warne,Hanns-Christian Mahler
  • Publisher : Springer
  • Release : 22 July 2018
GET THIS BOOKChallenges in Protein Product Development

In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein

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 : 30 December 2014
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

Interleukin Twelve

Interleukin Twelve
  • Author : Luciano Adorini
  • Publisher : Karger Publishers
  • Release : 25 February 1997
GET THIS BOOKInterleukin Twelve

The contributions collected in this volume represent the most recent findings, reviewed by leading scientists in the field, on several different aspects of IL-12 biology. The opening chapter analyzes the molecular regulation of IL-12 production and its immunomodulatory activities. This is followed by three contributions describing the structure of the IL-12 receptor and its role in determining the early events in the differentiation of T cell subsets. The modulation of IL-12 activities by other cytokines such as TGF-Beta, IFN-Gamma and

Therapeutic Fc-Fusion Proteins

Therapeutic Fc-Fusion Proteins
  • Author : Steven M. Chamow,Thomas Ryll,Henry B. Lowman,Deborah Farson
  • Publisher : John Wiley & Sons
  • Release : 18 December 2013
GET THIS BOOKTherapeutic Fc-Fusion Proteins

Edited by three pioneers in the field, each with longstanding experience in the biotech industry, and a skilled scientific writer, this is the first book to cover every step in the development and production of immunoglobulin Fc-fusion proteins as therapeutics for human disease: from choosing the right molecular design, to pre-clinical characterization of the purified product, through to batch optimization and quality control for large-scale cGMP production. The whole of the second part is devoted to case studies of Fc-fusion

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

Formulation, Characterization, and Stability of Protein Drugs

Formulation, Characterization, and Stability of Protein Drugs
  • Author : Rodney Pearlman,Y. John Wang
  • Publisher : Springer Science & Business Media
  • Release : 31 October 1996
GET THIS BOOKFormulation, Characterization, and Stability of Protein Drugs

Leading scientists offer detailed profiles of ten protein drugs currently in development. The case histories of these important new compounds are described from the perspective of their formulation, characterization, and stability. This ready reference also features recent data and an abundance of previously unpublished information. The in-depth coverage includes a highly useful compendium of degradation sites occurring in over 70 proteins. An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of