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Research ArticleResearch Paper

A biosafety toolbox for manufacturing with single-use systems

Richard Denk, Reinhold Maeck, Dirk Motzkus, Carola Dreier, Bernhard Steidle, Andreas Seiffert, Stefan Woog, Harald Eriksson, Charlotte Hieke, Chris Williams, Susanne Konrad, Joachim Regel and Sven Verguts
PDA Journal of Pharmaceutical Science and Technology May 2025, pdajpst.2025-000003.1; DOI: https://doi.org/10.5731/pdajpst.2025-000003.1
Richard Denk
SKAN AG
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  • For correspondence: richard.denk@skan.ch
Reinhold Maeck
Boehringer Ingelheim
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  • For correspondence: reinhold.maeck@boehringer-ingelheim.com
Dirk Motzkus
Boehringer Ingelheim
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  • For correspondence: dirk.motzkus@boehringer-ingelheim.com
Carola Dreier
Boehringer Ingelheim
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  • For correspondence: carola.dreier@boehringer-ingelheim.com
Bernhard Steidle
Boehringer Ingelheim
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Andreas Seiffert
Boehringer Ingelheim
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Stefan Woog
Boehringer Ingelheim
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  • For correspondence: stefan.woog@boehringer-ingelheim.com
Harald Eriksson
Biolamina
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Charlotte Hieke
Lonza
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  • For correspondence: annesophie-charlotte.hieke@lonza.com
Chris Williams
Roche
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Susanne Konrad
Roche
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Joachim Regel
Merck Group
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Sven Verguts
Merck Group
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Article Information

pdajpst.2025-000003.1
DOI 
https://doi.org/10.5731/pdajpst.2025-000003.1
PubMed 
40409979

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received January 24, 2025
  • Revision received April 13, 2025
  • Accepted May 4, 2025
  • Published online May 23, 2025.

Copyright & Usage 
Copyright © 2025, Parenteral Drug Association

Author Information

  1. Richard Denk (richard.denk{at}skan.ch),
  2. Reinhold Maeck (reinhold.maeck{at}boehringer-ingelheim.com),
  3. Dirk Motzkus (dirk.motzkus{at}boehringer-ingelheim.com),
  4. Carola Dreier (carola.dreier{at}boehringer-ingelheim.com),
  5. Bernhard Steidle (bernhard.steidle{at}boehringer-ingelheim.com),
  6. Andreas Seiffert (andreas.seiffert{at}boehringer-ingelheim.com),
  7. Stefan Woog (stefan.woog{at}boehringer-ingelheim.com),
  8. Harald Eriksson (Harald.eriksson{at}biolamina.com),
  9. Charlotte Hieke (annesophie-charlotte.hieke{at}lonza.com),
  10. Chris Williams (chris.williams.cw3{at}roche.com),
  11. Susanne Konrad (susanne.konrad{at}roche.com),
  12. Joachim Regel (joachim.regel{at}merckgroup.com) and
  13. Sven Verguts (sven.verguts{at}merckgroup.com)
  1. SKAN AG
  2. Boehringer Ingelheim
  3. Biolamina
  4. Lonza
  5. Roche
  6. Merck Group
  1. Corresponding Author: Richard Denk SKAN AG, Kreuzstrasse 5, 4123 Allschwil, Switzerland, E-Mail: richard.denk{at}skan.ch Cell-Phone: +41 79 529 0308

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PDA Journal of Pharmaceutical Science and Technology: 79 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 2
March/April 2025
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A biosafety toolbox for manufacturing with single-use systems
Richard Denk, Reinhold Maeck, Dirk Motzkus, Carola Dreier, Bernhard Steidle, Andreas Seiffert, Stefan Woog, Harald Eriksson, Charlotte Hieke, Chris Williams, Susanne Konrad, Joachim Regel, Sven Verguts
PDA Journal of Pharmaceutical Science and Technology May 2025, pdajpst.2025-000003.1; DOI: 10.5731/pdajpst.2025-000003.1

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A biosafety toolbox for manufacturing with single-use systems
Richard Denk, Reinhold Maeck, Dirk Motzkus, Carola Dreier, Bernhard Steidle, Andreas Seiffert, Stefan Woog, Harald Eriksson, Charlotte Hieke, Chris Williams, Susanne Konrad, Joachim Regel, Sven Verguts
PDA Journal of Pharmaceutical Science and Technology May 2025, pdajpst.2025-000003.1; DOI: 10.5731/pdajpst.2025-000003.1
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Keywords

  • BSL2
  • Single Use System
  • Single Use Operation
  • Biohazard waste
  • manufacturing engineering control
  • best practice of SU solution usage

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