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Die richtige Formulierung zum Erhalt der Qualität therapeutischer Proteine

  • Biotechnologie
  • Biopharmazeutika
  • Published:
BIOspektrum Aims and scope

Zusammenfassung

Die biotechnologische Herstellung therapeutischer Proteine ist ein aufwendiger und streng regulierter Prozess. Die richtige Formulierung und deren Entwicklung ist eine grundlegende Voraussetzung zur Gewährleistung der Qualität und des Erfolgs eines biopharmazeutischen Produktes.

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Literatur

  1. Shukla AA, Hubbard B, Tressel T et al. (2007) Downstream processing of monoclonal antibodies — application of platform approaches. J Chromatogr B 848:28–39

    Article  CAS  Google Scholar 

  2. Bergeman K, Eckermann C, Garidel P et al. (2007) Production and Downstream Processing. In: Dübel S (Hrsg) Handbook of Therapeutic Antibodies. Wiley-VCH, Weinheim

    Google Scholar 

  3. McNally EJ, Hastedt JE (2007) Protein Formulation and Delivery. Informa Healthcare Inc., New York

    Google Scholar 

  4. Mahler HC, Borchard G, Luessen H (2010) Characterization of Proteins and Related Analytical Techniques. In: Protein Pharmaceuticals. Editio Cantor Verlag, Aulendorf, 44–90

    Google Scholar 

  5. Shechter Y, Burstein Y, Patchornik A (1975) Selective oxidation of methionine residues in proteins. Biochemistry 14:4497–4503

    Article  PubMed  CAS  Google Scholar 

  6. Qi P, Volkin DB, Zhao H et al. (2008) Characterization of the photodegradation of a human IgG1 monoclonal antibody. J Pharm Sci 98:3117–3129

    Article  Google Scholar 

  7. Yu J (2000) Intentionally degrading protein pharmaceuticals to validate stability indicating analytical methods. Biopharm:46–50

  8. Grillo AO, Kane M, Penn N et al. (2010) Characterizing the formulation design space. Biopharm Int:30–39

  9. He F, Hogan S, Latypov RF et al. (2010) High throughput thermostability screening of monoclonal antibody formulations. J Pharm Sci 9:1707–1720

    Google Scholar 

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Correspondence to Alexander Faude.

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Alexander Faude (links) und Frank Kohne

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Faude, A., Kohne, F. Die richtige Formulierung zum Erhalt der Qualität therapeutischer Proteine. Biospektrum 17, 233–235 (2011). https://doi.org/10.1007/s12268-011-0035-1

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  • DOI: https://doi.org/10.1007/s12268-011-0035-1

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