Niazi S.K. Handbook of Biogeneric Therapeutic Proteins: regulatory, manufacturing, testing, and patent issues

CRC Press, 2006. — 554 p.Учебник описывающий довольно подробно производство и анализ биотехнологических продуктов а именно белков.
Handbook of Biogeneric Therapeutic Proteins is the eldest transcript to tender extended insurance coverage of all aspects of taxonomic group biologic products, from the quantifiable foundation done the mercantilism issues. This operable transcript includes spaciotemporal intelligence on establishing a trade set of contacts and securing restrictive compliments for biogeneric medical specialty products. The travel guide explains how to set up facilities to assembly the raw materials used in biological products and how to set up the end products. The essayist besides provides minutiae active the Chemistry, Manufacturing, and Controls (CMC) sector of the FDA's New Drug Application for Biological Products. -Features- Integrates all issues connected to selection, intellectual property protection, regulation, manufacturing and trialling Includes exhaustive preparation information more or less all natural goods accepted by the FDA Consolidates a fanlike catalogue of resource materials give or take a few suppliers, manufacturers, and experiment facilities Presents a singular beginning of mechanical guidelines for establishing productivity facilities for making life products About the Author Dr. Sarfaraz K. Niazi is the Chief Executive of Pharmaceutical Scientist, Inc., a consulting guests for caregiver and biotechnology industry. He has been touch in the licensing, technology transfer, procedure development, and keeper beneficial supermolecule engineering operations comprehensive. Dr. Niazi is as well authorised to try-out rights law earlier the US Patent and Trademark business establishment and an pioneer near piles of patents on new drugs and tablets 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