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Biotechnology: Quality Assurance and Validation (Drug Manufacturing Technology Series, V. 4)
 
 
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Biotechnology: Quality Assurance and Validation (Drug Manufacturing Technology Series, V. 4) (Hardcover)
by Kenneth E. Avis (Editor), Carmen M. Wagner (Editor), Vincent L. Wu (Editor) "As biotechnology has moved from research and development to the production and marketing of biopharmaceutical products, greater emphasis on quality assurance (QA) and validation of..." (more)
Key Phrases: overall clearance factor, biopharmaceutical processing, pharmaceutical quality control laboratories, New York, Federal Register, Marcel Dekker (more...)
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Product Description
Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a clear presentation of how to use filtration effectively, a synoptic view of cleaning procedures, and much more.

Product Details
  • Hardcover: 288 pages
  • Publisher: CRC; 1 edition (October 31, 1998)
  • Language: English
  • ISBN-10: 1574910892
  • ISBN-13: 978-1574910896
  • Product Dimensions: 9.5 x 6 x 0.8 inches
  • Shipping Weight: 1.1 pounds
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  • Amazon.com Sales Rank: #2,410,578 in Books (See Bestsellers in Books)
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Inside This Book (learn more)
First Sentence:
As biotechnology has moved from research and development to the production and marketing of biopharmaceutical products, greater emphasis on quality assurance (QA) and validation of the processes used has occurred. Read the first page
Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
overall clearance factor, biopharmaceutical processing, pharmaceutical quality control laboratories, virological safety, titer reduction, cleaning validation, model viruses, chromatography medium, change control program, clearance factors, virus removal, ligand leakage, chromatography media, working cell bank, clearance studies, biopharmaceutical products, tangential flow filtration, production column, viral clearance, process robustness, cell banks, validation master plan, viral contaminants, mechanical freezers, inactivation methods
Key Phrases - Capitalized Phrases (CAPs): (learn more)
New York, Federal Register, Marcel Dekker, Sepharose Fast Flow, Office of Regulatory Affairs, United States, Code of Federal Regulations, East Hills, American Type Culture Collection, International Conference, Pall Corp, Vox Sang, Parenteral Drug Association, Standard Operating Procedures, Barr Laboratories, Coumassie Brilliant Blue, Government Printing Office, Office of Regional Operations
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