Therapeutic protein drug products: practical approaches to formulation in the laboratory, manufacturing, and the clinic
Saved in:
| Format: | Electronic eBook |
|---|---|
| Language: | English |
| Published: |
Oxford
Woodhead Pub.
2012
|
| Series: | Woodhead Publishing series in biomedicine
no. 8 |
| Subjects: | |
| Online Access: | FAW01 Volltext |
| Item Description: | Includes bibliographical references and index Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed. Provides a list and description of commercially available therapeutic drug products and their formulationsA comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinicDiscusses recent topics including high protein concentration, phase separation, opalescence, and subvisible particles |
| Physical Description: | xxii, 181 pages : |
| ISBN: | 9781908818102 1908818107 9781907568183 |
Staff View
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| 500 | |a Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed. Provides a list and description of commercially available therapeutic drug products and their formulationsA comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinicDiscusses recent topics including high protein concentration, phase separation, opalescence, and subvisible particles | ||
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| 650 | 4 | |a Proteins / diagnostic use | |
| 650 | 4 | |a Biopharmaceutics / methods | |
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| dewey-full | 615.19 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
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| spelling | Therapeutic protein drug products practical approaches to formulation in the laboratory, manufacturing, and the clinic edited by Brian K. Meyer Oxford Woodhead Pub. 2012 xxii, 181 pages : txt rdacontent c rdamedia cr rdacarrier Woodhead Publishing series in biomedicine no. 8 Includes bibliographical references and index Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed. Provides a list and description of commercially available therapeutic drug products and their formulationsA comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinicDiscusses recent topics including high protein concentration, phase separation, opalescence, and subvisible particles Drug Design Proteins / diagnostic use Biopharmaceutics / methods Dosage Forms MEDICAL / Pharmacology bisacsh Protein drugs fast Protein drugs / Dosage forms fast Medizin Protein drugs Protein drugs Dosage forms Proteine (DE-588)4076388-2 gnd rswk-swf Arzneimittel (DE-588)4003115-9 gnd rswk-swf 1\p (DE-588)4143413-4 Aufsatzsammlung gnd-content Proteine (DE-588)4076388-2 s Arzneimittel (DE-588)4003115-9 s 2\p DE-604 Meyer, Brian K. Sonstige oth http://www.sciencedirect.com/science/book/9781907568183 Verlag URL des Erstveröffentlichers Volltext 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk 2\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Therapeutic protein drug products practical approaches to formulation in the laboratory, manufacturing, and the clinic Drug Design Proteins / diagnostic use Biopharmaceutics / methods Dosage Forms MEDICAL / Pharmacology bisacsh Protein drugs fast Protein drugs / Dosage forms fast Medizin Protein drugs Protein drugs Dosage forms Proteine (DE-588)4076388-2 gnd Arzneimittel (DE-588)4003115-9 gnd |
| subject_GND | (DE-588)4076388-2 (DE-588)4003115-9 (DE-588)4143413-4 |
| title | Therapeutic protein drug products practical approaches to formulation in the laboratory, manufacturing, and the clinic |
| title_auth | Therapeutic protein drug products practical approaches to formulation in the laboratory, manufacturing, and the clinic |
| title_exact_search | Therapeutic protein drug products practical approaches to formulation in the laboratory, manufacturing, and the clinic |
| title_full | Therapeutic protein drug products practical approaches to formulation in the laboratory, manufacturing, and the clinic edited by Brian K. Meyer |
| title_fullStr | Therapeutic protein drug products practical approaches to formulation in the laboratory, manufacturing, and the clinic edited by Brian K. Meyer |
| title_full_unstemmed | Therapeutic protein drug products practical approaches to formulation in the laboratory, manufacturing, and the clinic edited by Brian K. Meyer |
| title_short | Therapeutic protein drug products |
| title_sort | therapeutic protein drug products practical approaches to formulation in the laboratory manufacturing and the clinic |
| title_sub | practical approaches to formulation in the laboratory, manufacturing, and the clinic |
| topic | Drug Design Proteins / diagnostic use Biopharmaceutics / methods Dosage Forms MEDICAL / Pharmacology bisacsh Protein drugs fast Protein drugs / Dosage forms fast Medizin Protein drugs Protein drugs Dosage forms Proteine (DE-588)4076388-2 gnd Arzneimittel (DE-588)4003115-9 gnd |
| topic_facet | Drug Design Proteins / diagnostic use Biopharmaceutics / methods Dosage Forms MEDICAL / Pharmacology Protein drugs Protein drugs / Dosage forms Medizin Protein drugs Dosage forms Proteine Arzneimittel Aufsatzsammlung |
| url | http://www.sciencedirect.com/science/book/9781907568183 |
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