Overview

This volume addresses the particular problems associated with several classes of biotechnology products, and at the same time demonstrates that the principles are the same as in the development of small new chemical entities. The first chapter addresses FDA regulatory expectations for biotech products. The next chapters discuss general issues common to each class of biotech drug such as proteins, peptides and nucleic acids. The balance of the chapters deal with specific biotech drugs that have successfully made it into clinical trials. The reviews are written by renowned experts in their fields.

Full Product Details

Author:   Dale L. Oxender ,  Leonard E. Post
Publisher:   Springer-Verlag Berlin and Heidelberg GmbH & Co. KG
Imprint:   Springer-Verlag Berlin and Heidelberg GmbH & Co. K
Edition:   1999 ed.
Volume:   137
Dimensions:   Width: 15.50cm , Height: 1.60cm , Length: 23.50cm
Weight:   0.626kg
ISBN:  

9783540650256

ISBN 10:   3540650253
Pages:   248
Publication Date:   04 December 1998
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

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.

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