More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulato

chapter 1|28 pages

The Frontiers of Biotechnology

chapter 2|16 pages

Marketing Opportunities

chapter 3|58 pages

Manufacturing Overview

chapter 4|30 pages

Genetically Modified Cells

chapter 5|16 pages

Upstream Processing

chapter 6|40 pages

Manufacturing Systems

chapter 7|28 pages

Downstream Processing

chapter 8|20 pages

Purification Techniques

chapter 9|28 pages

Quality Assurance Systems

chapter 10|26 pages

Quality Control Systems

chapter 11|26 pages

Regulatory Affairs

chapter 12|46 pages

Intellectual Property Issues