Product Description
Handbook of Biogeneric Therapeutic Proteins is the first book to offer extensive coverage of all aspects of generic or biosimilar biological products, from the scientific basis through the marketing issues. This practical book includes comprehensive information on establishing a manufacturing system and securing regulatory approval for biogeneric pharmaceutical products. It explains how to establish facilities to manufacture the raw materials used in biological products and how to prepare finished products. The author also provides details about the Chemistry, Manufacturing, and Controls (CMC) section of the FDA's New Drug Application for Biological Products.
About the Author
Dr. Sarfaraz K. Niazi is the Chief Executive of Pharmaceutical Scientist, Inc., a consulting company for pharmaceutical and biotechnology industry. He has been involve in the licensing, technology transfer, process development, and turnkey therapeutic protein manufacturing operations worldwide. Dr. Niazi is also licensed to practice patent law before the US Patent and Trademark office and an inventor with scores of patents on new drugs and drug delivery systems
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
Appendix I: Recombinant DNA and Monoclonal Antibody Products Approved by FDA
Appendix II: Glossary of Terms
Appendix III: Bibliography
Index
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http://www.namipan.com/d/Handboo ... ec2d73bbe99f2024400
http://mihd.net/2146eu9/
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本帖最后由 arqiu 于 2008-5-8 10:47 编辑 ]
