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Biotechnology Reference from C.H.I.P.S.

Novel Therapeutic Proteins
Selected Case Studies
edited by Klaus Dembowsky
and Peter Stadler

This book describes medical applications of recombinant proteins and monoclonal antibodies, some of which have already been on the market for several years while others have only recently been launched.

It also highlights the manufacturing processes for individual products, the strategies that were taken by companies in the clinical development, and the hurdles that were encountered in clinical trials and had to be overcome before approval by regulatory authorities.

More than 350 biotechnological products are currently being tested in clinical trials or are already on the market. They allow treatment regimens for diseases that thus far could not be treated adequately with conventional chemical drugs. This book illustrates strategies to modify and improve the pharmacodynamic and pharmacokinetic properties of naturally occurring proteins thus paving the way for a new era in biotechnology.

Contents:

  1. INTRODUCTION AND OVERVIEW

    1. Medical Applications of Recombinant Proteins in Humans

  2. RECOMBINANT HORMONES

    1. Clinical Applications of Recombinant Human Erythropoietin
    2. Human Recombinant Growth Hormone
    3. Human Recombinant Follicle Stimulating Hormone

  3. RECOMBINANT CYTOKINES AND THEIR RECEPTORS

    1. Granulocyte Colony Stimulating Factor
    2. Interferon ß-1b in Multiple Sclerosis
    3. TNF-a -Receptors as Recombinant Proteins in Treatment of Rheumatoid Arthritis

  4. RECOMBINANT ENZYMES, ENZYME ACTIVATORS AND INHIBITORS

    1. Improvement of Principles of Nature: t-PA
    2. The Clinical Development of Recombinant Coagulation Factor VIII (Kogenate®) for the Treatment of Hemophilia A
    3. Aprotinin, Recombinant Aprotinin and Recombinant Aprotinin Mutants

  5. RECOMBINANT VACCINES

    1. Recombinant Hepatitis B Vaccines -- Characterization of the Viral Disease and Vaccine Production in the Methylotrophic Yeast, Hansenula polymorpha

  6. MONOCLONAL ANTIBODIES

    1. Therapeutic Applications of Monoclonal Antibodies: A Clinical Overview
    2. Antibody Therapy for Sepsis: Some Lessons Learned
    3. An Engineered Human Antibody for Chronic Therapy: CDP571
    4. The Evolution of ReoPro® Clinical Development

Index

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Novel Therapeutic Proteins
Selected Case Studies
edited by Klaus Dembowsky and Peter Stadler

358 pages • $199.00 + shipping
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