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Transfer von Antikörper-Präparaten: Allgemeine Betrachtungen im Rahmen einer Vorprojektphase

Transfer von Antikörper-Präparaten: Allgemeine Betrachtungen im Rahmen einer Vorprojektphase

          
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About the Book

Bachelorarbeit aus dem Jahr 2008 im Fachbereich Pharmazie, Note: 1, Campus02 Fachhochschule der Wirtschaft Graz (Innovationsmanagement), Sprache: Deutsch, Abstract: Als Vorbereitung für eine potentielle Produktübernahme durch einen Lohnabfüller wird eine Einführung in das Thema pharmazeutische Verarbeitung von Antikörpern gegeben. Diese allgemeinen Betrachtungen sollen in der Vorprojektsphase als Diskussionsgrundlage für konkrete Transfers dienen. In dieser Arbeit wird auf die Struktur und Funktionsweise von Antikörpern eingegangen, um daraus auf mögliche Risiken bei einem Produkttransfer schließen zu können. Es werden verschiedene gängige Primärpackmittel vorgestellt und hinsichtlich des Produkttransfers sowohl formale Aspekte als auch den Transport betreffende Risiken erörtert. Unterschiedliche Varianten der Produkteinbringung in den aseptischen Abfüllbereich sowie qualitäts-beeinflussende Prozessschritte, wie Begasung und Evakuierung der Gebinde, und produktberührende Komponenten im Rahmen der Abfüllung werden beschrieben. Abstract An introduction into the topic of pharmaceutical processing of antibodies is given as a preparation for a product transfer from the marketing authorisation holder to a contract manufacturer. These general observations are used as basis for discussions in the first stage of the transfer project. The structure and working mechanism of antibodies are described in this thesis to gather possible risks from their properties. Several kinds of common primary packaging are presented and formal aspects as well as risks related to the product transport are discussed. Different techniques of product introduction into the aseptic filling area are described. Quality influencing steps (e.g. vacuum and inert gassing) and components which are in contact with the solution are gauged according to adverse effects to the product.


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Product Details
  • ISBN-13: 9783640440849
  • Publisher: Grin Publishing
  • Binding: Paperback
  • Language: German
  • Returnable: N
  • Spine Width: 3 mm
  • Weight: 64 gr
  • ISBN-10: 3640440846
  • Publisher Date: 22 Oct 2009
  • Height: 210 mm
  • No of Pages: 40
  • Series Title: German
  • Sub Title: Allgemeine Betrachtungen im Rahmen einer Vorprojektphase
  • Width: 148 mm


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Transfer von Antikörper-Präparaten: Allgemeine Betrachtungen im Rahmen einer Vorprojektphase
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