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Pharmaceutical Book from C.H.I.P.S.

Handbook of Biogeneric Therapeutic Proteins
Regulatory, Manufacturing, Testing, and Patent Issues
by Sarfaraz K. Niazi

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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Handbook of Biogeneric Therapeutic Proteins
Regulatory, Manufacturing, Testing, and Patent Issues
by Sarfaraz K. Niazi

2005 584 pages $248.95 + shipping
Texas residents please add 6.75 % sales tax

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