Antibody Therapeutics - Production, Clinical Trials, and Strategic Issues

Antibody Therapeutics
Production, Clinical Trials, and Strategic Issues
Published: October 2001
By Rathin C. Das, Ph.D., M.B.A. & K. John Morrow, Jr., Ph.D.

Table of contents

Section Summary

1 Executive Summary

2 Introduction, Scope, and Objectives

3 Introduction and Overview of Monoclonal Antibody Manufacturing

Introduction
Expression Options
Bacterial Fermentor Technology
Yeast Expression Systems
Cell Culture
Hollow Fiber Bioreactors
Alternative Membrane-based Culture Systems
Insect Cell Culture
Glycosylation Issues in Cell Culture
Genetic Engineering of Cell Lines for Optimal Antibody Production
Optimization of Antibody Production through Nutritional Modifications
Transgenic Animals and Xenotransplantation
Avian Transgenics
Transgenic Plants
References

4 Overview of Purification, Formulation, and Analytical Methods

Introduction
Purification of Large-scale Quantities
Molecular Separation Technologies
Engineered Affinity Ligands
Broad-spectrum Ligands for Generalized Affinity Purification
Polyhistidine Tags for Affinity Capture
Other Varieties of Separation Technology
Spectrophotometric Monitoring of Downstream Processing
Clarification of Biological Fluids
Pathogen Removal
Formulation of Antibodies
Analytical Methods
References

5 Contract Manufacturing Organizations and Business Alliances

The Role of Contract Manufacturing Organizations
Selected Contract Manufacturing Organizations
Valuation of Contract Manufacturing Market
Alliances and Partnerships

6 Clinical Studies

Cancer
Inflammatory and Autoimmune Diseases
Allergic Disorders
Transplantation
Cardiovascular Diseases
Infectious Diseases
References

7 Patents and Intellectual Property

Perspectives and Status

8 Company Profiles

9 Business Trends and Strategic Issues

In-Depth Company Profiles
Abgenics
Abgenomics
AERES
Affitech
BioInvent
Cambrex
Cambridge Antibody Technology
Celltech Group
Charles River Laboratories
Chesapeake
Connex GmbH
Covance
DSM Biologics
Epicyte
Genentech
Genmab
Genzyme Transgenics
Goodwin Biotechnology
ICOS
IDEC
ImClone
KS Biomedix
Lonza
Marathon Biopharmaceuticals
Medarex
Millennium
Pall
Protein Design Lab
Peregrine
TransXenogen
Viventia

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Section	Summary
1	Executive Summary
2	Introduction, Scope, and Objectives
3	Introduction and Overview of Monoclonal Antibody Manufacturing Introduction Expression Options Bacterial Fermentor Technology Yeast Expression Systems Cell Culture Hollow Fiber Bioreactors Alternative Membrane-based Culture Systems Insect Cell Culture Glycosylation Issues in Cell Culture Genetic Engineering of Cell Lines for Optimal Antibody Production Optimization of Antibody Production through Nutritional Modifications Transgenic Animals and Xenotransplantation Avian Transgenics Transgenic Plants References
4	Overview of Purification, Formulation, and Analytical Methods Introduction Purification of Large-scale Quantities Molecular Separation Technologies Engineered Affinity Ligands Broad-spectrum Ligands for Generalized Affinity Purification Polyhistidine Tags for Affinity Capture Other Varieties of Separation Technology Spectrophotometric Monitoring of Downstream Processing Clarification of Biological Fluids Pathogen Removal Formulation of Antibodies Analytical Methods References
5	Contract Manufacturing Organizations and Business Alliances The Role of Contract Manufacturing Organizations Selected Contract Manufacturing Organizations Valuation of Contract Manufacturing Market Alliances and Partnerships
6	Clinical Studies Cancer Inflammatory and Autoimmune Diseases Allergic Disorders Transplantation Cardiovascular Diseases Infectious Diseases References
7	Patents and Intellectual Property Perspectives and Status
8	Company Profiles
9	Business Trends and Strategic Issues
	In-Depth Company Profiles Abgenics Abgenomics AERES Affitech BioInvent Cambrex Cambridge Antibody Technology Celltech Group Charles River Laboratories Chesapeake Connex GmbH Covance DSM Biologics Epicyte Genentech Genmab Genzyme Transgenics Goodwin Biotechnology ICOS IDEC ImClone KS Biomedix Lonza Marathon Biopharmaceuticals Medarex Millennium Pall Protein Design Lab Peregrine TransXenogen Viventia