Development and Manufacture of Protein Pharmaceuticals:
In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosa...
Gespeichert in:
| Weitere Verfasser: | , |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Boston, MA
Springer US
2002
|
| Schriftenreihe: | Pharmaceutical Biotechnology
14 |
| Schlagworte: | |
| Online-Zugang: | UBR01 URL des Erstveröffentlichers |
| Zusammenfassung: | In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality |
| Beschreibung: | 1 Online-Ressource (XX, 464 p) |
| ISBN: | 9781461505495 |
| DOI: | 10.1007/978-1-4615-0549-5 |
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| 520 | |a In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality | ||
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| dewey-ones | 615 - Pharmacology and therapeutics |
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| discipline | Chemie / Pharmazie Medizin |
| doi_str_mv | 10.1007/978-1-4615-0549-5 |
| format | Electronic eBook |
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| id | DE-604.BV046148681 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T08:36:34Z |
| institution | BVB |
| isbn | 9781461505495 |
| language | English |
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| spelling | Development and Manufacture of Protein Pharmaceuticals edited by Steve L. Nail, Michael J. Akers Boston, MA Springer US 2002 1 Online-Ressource (XX, 464 p) txt rdacontent c rdamedia cr rdacarrier Pharmaceutical Biotechnology 14 In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality Pharmacology/Toxicology Pharmacy Biochemistry, general Industrial Chemistry/Chemical Engineering Biotechnology Toxicology Biochemistry Chemical engineering Nail, Steve L. edt Akers, Michael J. edt Erscheint auch als Druck-Ausgabe 9781461351276 Erscheint auch als Druck-Ausgabe 9780306467455 Erscheint auch als Druck-Ausgabe 9781461505501 https://doi.org/10.1007/978-1-4615-0549-5 Verlag URL des Erstveröffentlichers Volltext |
| spellingShingle | Development and Manufacture of Protein Pharmaceuticals Pharmacology/Toxicology Pharmacy Biochemistry, general Industrial Chemistry/Chemical Engineering Biotechnology Toxicology Biochemistry Chemical engineering |
| title | Development and Manufacture of Protein Pharmaceuticals |
| title_auth | Development and Manufacture of Protein Pharmaceuticals |
| title_exact_search | Development and Manufacture of Protein Pharmaceuticals |
| title_full | Development and Manufacture of Protein Pharmaceuticals edited by Steve L. Nail, Michael J. Akers |
| title_fullStr | Development and Manufacture of Protein Pharmaceuticals edited by Steve L. Nail, Michael J. Akers |
| title_full_unstemmed | Development and Manufacture of Protein Pharmaceuticals edited by Steve L. Nail, Michael J. Akers |
| title_short | Development and Manufacture of Protein Pharmaceuticals |
| title_sort | development and manufacture of protein pharmaceuticals |
| topic | Pharmacology/Toxicology Pharmacy Biochemistry, general Industrial Chemistry/Chemical Engineering Biotechnology Toxicology Biochemistry Chemical engineering |
| topic_facet | Pharmacology/Toxicology Pharmacy Biochemistry, general Industrial Chemistry/Chemical Engineering Biotechnology Toxicology Biochemistry Chemical engineering |
| url | https://doi.org/10.1007/978-1-4615-0549-5 |
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