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Research ArticleResearch

Replacing the Emulsion for Bake-on Siliconization of Containers—Comparison of Emulsion Stability and Container Performance in the Context of Protein Formulations

Fabian Moll, Karoline Bechtold-Peters, James Mellman, JÜrgen Sigg and Wolfgang Friess
PDA Journal of Pharmaceutical Science and Technology March 2022, 76 (2) 89-108; DOI: https://doi.org/10.5731/pdajpst.2021.012640
Fabian Moll
1Department of Pharmacy, Pharmaceutical Technology & Biopharmaceutics, Ludwig-Maximilians-University Munich, Germany;
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Karoline Bechtold-Peters
2Technical Research and Development (TRD) Biologics, Novartis Pharma AG, Basel, Switzerland; and
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James Mellman
2Technical Research and Development (TRD) Biologics, Novartis Pharma AG, Basel, Switzerland; and
3SHL Medical AG, Zug, Switzerland
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JÜrgen Sigg
2Technical Research and Development (TRD) Biologics, Novartis Pharma AG, Basel, Switzerland; and
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Wolfgang Friess
1Department of Pharmacy, Pharmaceutical Technology & Biopharmaceutics, Ludwig-Maximilians-University Munich, Germany;
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  • For correspondence: wolfgang.friess@lrz.uni-muenchen.de
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Article Information

vol. 76 no. 2 89-108
DOI 
https://doi.org/10.5731/pdajpst.2021.012640
PubMed 
35365551

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 1, 2022.

Article Versions

  • previous version (August 16, 2021 - 09:44).
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Copyright & Usage 
© PDA, Inc. 2022

Author Information

  1. Fabian Moll1,
  2. Karoline Bechtold-Peters2,
  3. James Mellman2,3,
  4. JÜrgen Sigg2 and
  5. Wolfgang Friess1,*
  1. 1Department of Pharmacy, Pharmaceutical Technology & Biopharmaceutics, Ludwig-Maximilians-University Munich, Germany;
  2. 2Technical Research and Development (TRD) Biologics, Novartis Pharma AG, Basel, Switzerland; and
  3. 3SHL Medical AG, Zug, Switzerland
  1. ↵*Corresponding Author: Department of Pharmacy, Pharmaceutical Technology & Biopharmaceutics, Butenandtstrasse 5, 81377 Munich, Germany; Telephone: +49 89 2180 77017; E-mail: wolfgang.friess{at}lrz.uni-muenchen.de
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This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking.

  • Impact of autoclavation on baked-on siliconized containers for biologics
    Fabian Moll, Karoline Bechtold-Peters, Wolfgang Friess
    European Journal of Pharmaceutics and Biopharmaceutics 2023 187
  • Evaluation of a novel silicone oil free primary packaging system with PTFE-based barrier stopper for biologics
    Fabian Moll, Karoline Bechtold-Peters, Wolfgang Friess
    European Journal of Pharmaceutics and Biopharmaceutics 2023 190
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PDA Journal of Pharmaceutical Science and Technology: 76 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 2
March/April 2022
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Replacing the Emulsion for Bake-on Siliconization of Containers—Comparison of Emulsion Stability and Container Performance in the Context of Protein Formulations
Fabian Moll, Karoline Bechtold-Peters, James Mellman, JÜrgen Sigg, Wolfgang Friess
PDA Journal of Pharmaceutical Science and Technology Mar 2022, 76 (2) 89-108; DOI: 10.5731/pdajpst.2021.012640

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Replacing the Emulsion for Bake-on Siliconization of Containers—Comparison of Emulsion Stability and Container Performance in the Context of Protein Formulations
Fabian Moll, Karoline Bechtold-Peters, James Mellman, JÜrgen Sigg, Wolfgang Friess
PDA Journal of Pharmaceutical Science and Technology Mar 2022, 76 (2) 89-108; DOI: 10.5731/pdajpst.2021.012640
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Keywords

  • Bake-on siliconization
  • Protein formulation
  • Drug/device combination product
  • Primary packaging
  • Biopharmaceuticals
  • Silicone interaction
  • Silicone layer characterization

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