Aaps advances in the pharmaceutical sciences - 9783319906010 - challenges in protein product development: 38 (9 risultati)

Lingua: Inglese
Editore: Springer, 2018
Serie: Libro 27 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Da: SpringBooks, Berlin, GermaniaSpringBooks
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Lingua: Inglese
Editore: Springer, 2018
Serie: Libro 27 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Lingua: Inglese
Editore: Springer, 2018
Serie: Libro 27 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Condizione: New. In.

Lingua: Inglese
Editore: Springer, 2018
Serie: Libro 27 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Da: AHA-BUCH GmbH, Einbeck, GermaniaAHA-BUCH GmbH
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Buch. Condizione: Neu. Druck auf Anfrage Neuware - Printed after ordering - In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of… therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration,solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

Challenges in Protein Product Development
Warne, Nicholas W. (Editor)/ Mahler, Hanns-christian (Editor)
Lingua: Inglese
Editore: Springer Verlag, 2018
Serie: Libro 27 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Da: Revaluation Books, Exeter, Regno UnitoRevaluation Books
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Hardcover. Condizione: Brand New. 616 pages. 9.25x6.10x1.60 inches. In Stock.

Lingua: Inglese
Editore: Springer, 2018
Serie: Libro 27 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Da: Brook Bookstore On Demand, Napoli, NA, ItaliaBrook Bookstore On Demand
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Condizione: new. Questo è un articolo print on demand.

Lingua: Inglese
Editore: Springer International Publishing, 2018
Serie: Libro 27 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Da: moluna, Greven, Germaniamoluna
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Gebunden. Condizione: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Discusses the challenges faced in biotechnology dosage form developmentProvides practical and applied guidance in many areas including stability, microbiology and manufacturing, as well as case studies in l…ife-cycle management Includes comp.

Lingua: Inglese
Editore: Springer International Publishing, Springer Nature Switzerland Jul 2018, 2018
Serie: Libro 27 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Da: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermaniaBuchWeltWeit Ludwig Meier e.K.
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Buch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns.… As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration,solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies. 616 pp. Englisch.

Lingua: Inglese
Editore: Springer, Springer Jul 2018, 2018
Serie: Libro 27 di 38 - AAPS Advances in the Pharmaceutical Sciences
- Rilegato
- Print on Demand
Da: buchversandmimpf2000, Emtmannsberg, BAYE, Germaniabuchversandmimpf2000
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Buch. Condizione: Neu. This item is printed on demand - Print on Demand Titel. Neuware -Discusses the challenges faced in biotechnology dosage form developmentProvides practical and applied guidance in many areas including stability, microbiology and manufacturing, as well as case studies in life-cycle managementIncludes compreh…ensive information on the use of polysorbate exipients in formulationSpringer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 616 pp. Englisch.