Monoclonal Antibodies
eBook - ePub

Monoclonal Antibodies

Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product

  1. 224 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Monoclonal Antibodies

Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product

About this book

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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Yes, you can access Monoclonal Antibodies by Steven Shire in PDF and/or ePUB format, as well as other popular books in Medicine & Immunology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
Woodhead Publishing
Year
2015
Print ISBN
9780081002964
eBook ISBN
9780081002971
Topic
Medicine
Subtopic
Immunology

Table of contents

  1. Cover image
  2. Title page
  3. Table of Contents
  4. Related titles
  5. Copyright
  6. List of figures
  7. List of tables
  8. About the author
  9. Preface
  10. 1. Introduction
  11. 2. Analytical tools used in the formulation and assessment of stability of monoclonal antibodies (mAbs)
  12. 3. Stability of monoclonal antibodies (mAbs)
  13. 4. Formulation of proteins and monoclonal antibodies (mAbs)
  14. 5. Challenges in the intravenous (IV) administration of monoclonal antibodies (mAbs)
  15. 6. Challenges in the subcutaneous (SC) administration of monoclonal antibodies (mAbs)
  16. 7. Strategies to deal with challenges of developing high-concentration subcutaneous (SC) formulations for monoclonal antibodies (mAbs)
  17. 8. Development of delivery device technology to deal with the challenges of highly viscous mAb formulations at high concentration
  18. 9. The molecular basis of high viscosity of monoclonal antibodies (mAbs) at high concentration
  19. 10. The future of monoclonal antibodies (mAbs) as therapeutics and concluding remarks
  20. Index