Novel Therapeutics from Modern Biotechnology

1. Front Matter

   Pages I-XVII

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2. Overview of Regulatory Expectations for Introducing Novel Therapies into Clinical Trials

   • J. A. Cavagnaro, M. A. Serabian

   Pages 1-12

3. Preparation of Clinical Trial Supplies of Biopharmaceuticals

   • A. S. Lubiniecki, J. C. Erickson, C. L. Nolan, R. G. Scott, P. J. Shadle, T. M. Smith et al.

   Pages 13-31

4. Proteins as Drugs: Analysis, Formulation and Delivery

   • C. R. Middaugh, R. Pearlman

   Pages 33-58

5. Strategies for Dealing With the Immunogenicity of Therapeutic Proteins

   • M. L. Nucci, R. G. L. Shorr, A. Abuchowski

   Pages 59-88

6. Targeted Toxin Hybrid Proteins

   • R. J. Kreitman, I. Pastan

   Pages 89-110

7. SB 209763: A Humanized Monoclonal Antibody for the Prophylaxis and Treatment of Respiratory Syncytial Virus Infection

   • T. G. Porter, S. G. Griego, T. K. Hart, D. E. Everitt, S. B. Dillon

   Pages 111-129

8. Preclinical Development of Antisense Therapeutics

   • A. A. Levin, S. P. Henry, C. F. Bennett, D. L. Cole, G. E. Hardee, G. S. Srivatsa

   Pages 131-163

9. Formulation and Delivery of Nucleic Acids

   • H. E. J. Hofland, L. Huang

   Pages 165-192

10. Safe, Efficient Production of Retroviral Vectors

    • H. Kotani, G. J. Mcgarrity

    Pages 193-219

11. Clinical Systems for the Production of Cells and Tissues for Human Therapy

    • R. D. Armstrong, M. R. Koller, J. Maluta, W. C. Ogier

    Pages 221-241

12. Back Matter

    Pages 243-248

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A cover story of Business Week Magazine in January 1984 stated "Biotech Comes of Age". In February 1986, Venture Magazine had a cover article entitled "The Biotech Revolution is Here". This article went on to say "New Genetic Technologies Will Transform Our Lives". These announcements were made many years after the first biotechnology companies, such as Genentech, Cetus, Amgen and Biogen, were formed-to commercialize the "New Biology". . At the time of writing this book, there are over 1300 biotech companies developing new technologies or identifying potential biotech drugs. Most of these companies were started in the height of the "high-technology hype", although companies are still forming as the technology advances. A more recent survey showed only a relatively small number of Food and Drug Administration (FDA) approvals among over several hundred biotech­ nology products now in clinical trial. One could ask why it has taken so long to produce biotechnology products. Part of the reason is that each new class of biotech products brings with it a set of problems that need to be solved before they enter clinical trials. These problems are often unique to biotechnology products, such as peptides, proteins, monoclonal antibodies, nucleic acids and cellular therapies.

• Downstream Processing
• Expression
• Nucleotide
• Tissue Engineering
• Vivo
• biotechnology
• chemistry
• chromatography
• gene expression
• gene therapy
• preparation
• protein
• proteins
• recombinant proteins
• tissue

• Parke-Davis Pharmaceutical Research, Ann Arbor, USA

  Dale L. Oxender, Leonard E. Post

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