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.
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Inside This Book
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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 New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
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 New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
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11
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cite this book:
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- Public Finance by J. Richard Aronson on page 246
- Director of Operations (Career Examination Passbooks) by Jack Rudman in Front Matter
- Sterile Pharmaceutical Products: Process Engineering Applications (Drug Manufacturing Technology Series, V. 1) by Kenneth E. Avis in Front Matter
- Good Computer Validation Practices: Common Sense Implementation by Teri Stokes on page 90
- Pharmaceutical Unit Operations: Coating (Asis Monograph Series) by Kenneth E. Avis in Front Matter
- Audit by Mail: Time and Cost Effective GMP Audit Tool by John Lyall in Back Matter
- The GCP Harmonization Handbook by Donald E. Maynard in Back Matter
- International Clinical Trials: A Guidebook and Compendium of National Drug Laws, Two-Volume Set by Dominique Brunier in Back Matter
- Computer Validation Compliance: A Quality Assurance Perspective by Mary Ellen Double in Back Matter
- Cryopreservation: Applications in Pharmaceuticals and Biotechnology (Drug Manufacturing Technology Series) by Kenneth E. Avis in Front Matter
See all 11 books citing this book
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