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. Finally, 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.
Foreword written by Jürgen Drews.
Mục lục
Foreword (Juergen Drews)
Preface (Klaus Dembowsky and Peter Stadler)
INTRODUCTION AND OVERVIEW
Medical Applications of Recombinant Proteins in Humans
Gayle Delmonte Wetzel
RECOMBINANT HORMONES
Clinical Applications of Recombinant Human Erythropoietin (Dimitrios Spentzos and Arthur J. Sytkowski)
Human Recombinant Growth Hormone (Carmen Ariznavarreta Ruiz and Jesús A.F. Tresguerres)
Human Recombinant Follicle Stimulating Hormone (Follitropin-a) (José A. Peinado, Colin M. Howles, and Jesús A.F. Tresguerres)
RECOMBINANT CYTOKINES AND THEIR RECEPTORS
Granulocyte Colony Stimulating Factor (G-CSF) (Karl Welte)
Interferon b-1b in Multiple Sclerosis (Bernd Aufdembrinke, Reinhard Horowski, and Joachim-Friedrich Kapp)
TNF-a -Receptors as Recombinant Proteins in Treatment of Rheumatoid Arthritis (Hanns-Martin Lorenz and Joachim R. Kalden)
RECOMBINANT ENZYMES, ENZYME ACTIVATORS AND INHIBITORS
Improvement of Principles of Nature: t-PA (Rolf G. Werner and Gerhard Heusel)
The Clinical Development of Recombinant Coagulation Factor VIII (KogenateÒ) for the Treatment of Hemophilia A (Peter J. Larson)
Aprotinin, Recombinant Aprotinin and Recombinant Aprotinin Mutants (Klaus Dembowsky and Werner Schroeder)
RECOMBINANT VACCINES
Recombinant Hepatitis B Vaccines — Characterization of the Viral Disease and Vaccine Production in the Methylotrophic Yeast, Hansenula polymorpha (Stephan Schaefer, Michael Piontek, Sang-Jeom Ahn, Adam Papendieck, Zbigniew A. Janowicz and Gerd Gellissen)
MONOCLONAL ANTIBODIES
Therapeutic Applications of Monoclonal Antibodies: A Clinical Overview (Mark Sopwith)
Antibody Therapy for Sepsis: Some Lessons Learned (Steven M. Opal)
An Engineered Human Antibody for Chronic Therapy: CDP571 (Mark Sopwith and Sue Stephens)
The Evolution of Reo Pro(r) Clinical Development (Catherine F. Farrell, Elliot S. Barnathan and Harlan F. Weisman)
Index
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