Novel Therapeutics from Modern Biotechnology

From Laboratory to Human Testing
Herausgegeben:Oxender, Dale L.; Post, Leonard E.

• Broschiertes Buch

Produktbeschreibung

The book gives an informal introduction to mathematical and computational principles governing numerical analysis, as well as practical guidelines for using over 130 elaborate numerical analysis routines. It develops detailed formulas for both standard and rarely found algorithms, including many variants for linear and non-linear equation solvers, one- and two-dimensional splines of various kinds, numerical quadrature and cubature formulas of all known stable orders, and stable IVP and BVP solvers, even for stiff systems of differential equations. The descriptions of the algorithms are very detailed and focus on their implementation, giving sensible decision criteria to choose among the algorithms and describing the merits and demerits of each one. The authors see "Numerical Algorithms with C" as a depository of highly useful and effective algorithms and codes for the scientist and engineer who needs to have direct access to such algorithms. The programs are all field tested. The enclosed CD-ROM contains all computer codes, a compiler and a test bed of programs and data for most of the algorithms. Each test program includes detailed comments and describes available options, all clearly marked, with a complete list of error codes, etc.

---

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.

Produktdetails

• Handbook of Experimental Pharmacology 137
• Verlag: Springer / Springer Berlin Heidelberg / Springer, Berlin
• Artikelnr. des Verlages: 978-3-540-65927-3
• 1999.
• Seitenzahl: 272
• Erscheinungstermin: 23. Juli 1999
• Englisch
• Abmessung: 235mm x 155mm x 15mm
• Gewicht: 406g
• ISBN-13: 9783540659273
• ISBN-10: 3540659277
• Artikelnr.: 08347068

Inhaltsangabe

1 Overview of Regulatory Expectations for Introducing Novel Therapies into Clinical Trials.- A. Introduction.- B. Roles of Regulatory Scientists.- C. Product Development and Availability.- D. Data Requirements.- E. Manufacturing.- F. Preclinical Safety Testing.- G. Case-By-Case Approach.- H. Testing Goals.- I. Study Design.- J. Defining Exposure.- K. Product-Specific Concerns.- L. Accessibility of Preclinical Safety Data.- M. Clinical Studies.- N. Summary.- References.- 2 Preparation of Clinical Trial Supplies of Biopharmaceuticals.- A. Introduction.- B. Preclinical Studies.- C. Clinical Supplies.- D. Purification of rDNA-Derived Anti-RSV MAb.- E. Product Quality Issues.- F. Process Design and Validation.- G. Process Economics and the Future of Chromatography.- H. Conclusions.- References.- 3 Proteins as Drugs: Analysis, Formulation and Delivery.- A. Introduction.- B. The Analysis of Protein Pharmaceuticals.- C. Formulation.- D. Delivery.- References.- 4 Strategies for Dealing With the Immunogenicity of Therapeutic Proteins.- A. Introduction.- B. Case Histories of Protein Therapeutic Development.- C. Strategies Under Development for Increasing the Therapeutic Value of Proteins and Peptides.- D. Choosing the Proper Strategy for a Protein Therapeutic.- E. The Future of Protein Therapeutics.- References.- 5 Targeted Toxin Hybrid Proteins.- A. Introduction.- B. Preclinical Development of Anti-Tac(Fv) Toxins.- C. Preclinical Development of Inerleukin 6-PE4E.- D. Summary.- References.- 6 SB 209763: A Humanized Monoclonal Antibody for the Prophylaxis and Treatment of Respiratory Syncytial Virus Infection.- A. Introduction.- B. Early Challenges in the Development of SB 209763.- C. Preclinical Evaluation Prior to Testing in Humans.- D. Challenges for the Early Clinical Development of SB 209763.- E. Conclusion.- References.- 7 Preclinical Development of Antisense Therapeutics.- A. Introduction.- B. Pharmacology of Antisense Oligodeoxynucleotides.- C. Pharmacokinetics and Toxicity of Oligodeoxynucleotide Therapeutics.- D. Chemistry, Manufacture and Control of Phosphorothioate Oligodeoxynucleotide Drugs.- E. Formulation and Drug Delivery of Oligodeoxynucleotides.- F. Summary.- References.- 8 Formulation and Delivery of Nucleic Acids.- A. Introduction.- B. Formulation of DNA.- C. Delivery to Target Cells.- D. Cell Entry.- E. Endosomal Release.- F. Nuclear Localization.- G. Gene Expression.- References.- 9 Safe, Efficient Production of Retroviral Vectors.- A. Introduction.- B. Vectors.- C. Production of Retroviral Vectors.- D. Downstream Processing.- E. GMP Production of Retroviral Vectors.- F. In-Process Assays.- G. Quality Control.- H. Safety.- I. Summary and Conclusions.- References.- 10 Clinical Systems for the Production of Cells and Tissues for Human Therapy.- A. Introduction.- B. Cell Therapy and Tissue Engineering.- C. Critical Requirements for Ex Vivo Cell Production.- D. Cell-Culture Devices and Procedures.- E. Applications for On-Site Delivery of Therapeutic Cell Production.- F. Summary.- References.