Process Validation in Manufacturing of Biophamaceuticals: Guidelines, Current Practices and Industrial Case Studies (Record no. 16149)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 01323nam a2200169Ia 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 140223b2005 xxu||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781574445169 |
| Terms of availability | 0.00 |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.152 |
| Item number | PRO |
| 245 ## - TITLE STATEMENT | |
| Title | Process Validation in Manufacturing of Biophamaceuticals: Guidelines, Current Practices and Industrial Case Studies |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication, distribution, etc | Boca Raton |
| Name of publisher, distributor, etc | Taylor & Francis |
| Date of publication, distribution, etc | 2005 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 578p |
| 500 ## - GENERAL NOTE | |
| General note | Written by top authorities in process validation, this reference explores current trends in the field and strategies for selecting the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of case studies that showcase various techniques and approaches in the validation of biopharmaceutical processes. These include guidance on determining the life spans of chromatography and filtration media, process characterization and techniques for scaling-down unit operations in biopharmaceutical manufacturing, examples of contamination events, and practical methods for testing raw materials and in-process samples during various manufacturing stages. |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Rathore, Anurag Singh |
| Relator term | Editor |
| 9 (RLIN) | 104922 |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Sofer, Gail |
| Relator term | Editor |
| 9 (RLIN) | 104923 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Item type | Book |
| 995 ## - RECOMMENDATION 995 [LOCAL, UNIMARC FRANCE] | |
| Origin of item (home branch) (free text) | Pharmacy Reference |
| Genre | P0001867 |
| Section | 615.152 |
| Recipient parent organisation code | P0001867 |
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