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Research ArticlePDA Paper

Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations

Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
Sylvia Anger
1Bayer, Berlin Germany;
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Cecile Begat
2Bayer AG, Basel, Switzerland;
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Vincent Crnko
3Becton, Dickinson and Company, Grenoble France;
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GianMaurizio Fantozzi
4Stevenato Group, Via Molinella, Padua, Italy;
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Wadi Farach
5Amgen Inc., Thousand Oaks, CA, USA;
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Sean Fitzpatrick
6Gerresheimer, Vineland, NJ, USA;
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Brian Gallagher
7Aptar Pharma, Congers, NY, USA;
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Stefan Huelsmann
8Bayer AG, Kaiser-Wilhelm-Allee, Leverkusen, Germany;
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Paul Kinsey
9GlaxoSmithKline, Durham, United Kingdom;
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Vincent Langlade
10SGD Pharma Packaging Group Inc., Puteaux, Haut de Seine, France;
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Ghislain Lefevre
11Becton, Dickinson and Company, Grenoble France;
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Elise Legendre
12SANOFI, Paris, France;
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Kevin McLean
13SGD Pharma Packaging Group Inc., Puteaux, Haut de Seine, France;
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Jahanvi Miller
14Parenteral Drug Association, Bethesda, MD, USA;
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Ravi Patel
15West Pharmaceutical Services, Exton, PA, USA;
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Anthony Perry
16Schott North America, Inc., Lebanon, PA, USA;
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Herve Soukiassian
17Becton Dickinson, Le Pont-de-Claix, France;
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Amy Stanton
18Amgen Inc., Thousand Oaks, CA, USA;
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  • For correspondence: amgonzal@amgen.com
Dorothee Streich
19Bayer AG, Kaiser-Wilhelm-Allee, Leverkusen, Germany;
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Christopher Timmons
20Corning, Painted Post, NY, USA;
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DAVID Vaneylen
21Datwyler Pharma Packaging, Alken, Belgium;
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Tony van Hoose
22Global Aseptic Process Solutions, LLC, Bangor, PA, USA;
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Linda Wildling
23Takeda, Singen, Germany; and
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Mike Windover
24Gerresheimer, Vineland, NJ, USA
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Article Information

vol. 73 no. 6 635-647
DOI 
https://doi.org/10.5731/pdajpst.2019.010645
PubMed 
31420504

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 10, 2019.

Article Versions

  • previous version (August 16, 2019 - 04:26).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Sylvia Anger1,
  2. Cecile Begat2,
  3. Vincent Crnko3,
  4. GianMaurizio Fantozzi4,
  5. Wadi Farach5,
  6. Sean Fitzpatrick6,
  7. Brian Gallagher7,
  8. Stefan Huelsmann8,
  9. Paul Kinsey9,
  10. Vincent Langlade10,
  11. Ghislain Lefevre11,
  12. Elise Legendre12,
  13. Kevin McLean13,
  14. Jahanvi Miller14,
  15. Ravi Patel15,
  16. Anthony Perry16,
  17. Herve Soukiassian17,
  18. Amy Stanton18,*,
  19. Dorothee Streich19,
  20. Christopher Timmons20,
  21. DAVID Vaneylen21,
  22. Tony van Hoose22,
  23. Linda Wildling23 and
  24. Mike Windover24
  1. 1Bayer, Berlin Germany;
  2. 2Bayer AG, Basel, Switzerland;
  3. 3Becton, Dickinson and Company, Grenoble France;
  4. 4Stevenato Group, Via Molinella, Padua, Italy;
  5. 5Amgen Inc., Thousand Oaks, CA, USA;
  6. 6Gerresheimer, Vineland, NJ, USA;
  7. 7Aptar Pharma, Congers, NY, USA;
  8. 8Bayer AG, Kaiser-Wilhelm-Allee, Leverkusen, Germany;
  9. 9GlaxoSmithKline, Durham, United Kingdom;
  10. 10SGD Pharma Packaging Group Inc., Puteaux, Haut de Seine, France;
  11. 11Becton, Dickinson and Company, Grenoble France;
  12. 12SANOFI, Paris, France;
  13. 13SGD Pharma Packaging Group Inc., Puteaux, Haut de Seine, France;
  14. 14Parenteral Drug Association, Bethesda, MD, USA;
  15. 15West Pharmaceutical Services, Exton, PA, USA;
  16. 16Schott North America, Inc., Lebanon, PA, USA;
  17. 17Becton Dickinson, Le Pont-de-Claix, France;
  18. 18Amgen Inc., Thousand Oaks, CA, USA;
  19. 19Bayer AG, Kaiser-Wilhelm-Allee, Leverkusen, Germany;
  20. 20Corning, Painted Post, NY, USA;
  21. 21Datwyler Pharma Packaging, Alken, Belgium;
  22. 22Global Aseptic Process Solutions, LLC, Bangor, PA, USA;
  23. 23Takeda, Singen, Germany; and
  24. 24Gerresheimer, Vineland, NJ, USA
  1. ↵* Corresponding Author: Amgen, Thousand Oaks, CA. E-mail: amgonzal@amgen.com
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PDA Journal of Pharmaceutical Science and Technology: 73 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 6
November/December 2019
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Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling, Mike Windover
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 635-647; DOI: 10.5731/pdajpst.2019.010645
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Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling, Mike Windover
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 635-647; DOI: 10.5731/pdajpst.2019.010645

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