Handbook of Biogeneric Therapeutic Proteins is the first book to review and analyze the status of biotechnology, regulatory environment, manufacturing methodologies, testing requirements and intellectual property issues.

Features:

• Provides formulation details on all FDA approved products, a glossary of terms, and a bibliography of literature on recombinant technologies
• Describes the patenting process, intellectual property evaluation in recombinant science, and lists patent expiry dates for key drugs
• Covers every commercial and developmental stage medium for expression of proteins, including details on making genetically modified cells to commercial yields of GMP-grade therapeutic proteins
• Discusses the current status of regulatory approvals, mechanisms for filing regulatory applications and the controversies involved in generic therapeutic protein development

Contents

• The Frontiers of Biotechnology
• Marketing Opportunities
• Manufacturing Overview
• Genetically Modified Cells
• Upstream Processing
• Manufacturing Systems
• Downstream Processing
• Purification Techniques
• Quality Assurance Systems
• Quality Control Systems
• Regulatory Affairs
• Intellectual Property Issues

Appendices

• Recombinant DNA and Monoclonal Antibody Products Approved by FDA
• Glossary of Terms

Index

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