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Research ArticleResearch

Leachables Analysis from a Closed Connected Single-Use mAb Purification Process

Alfred Haglind, Emil Håkansson, Nils Wallménius, Annelie Hansson and Karin Isaksson
PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 643-680; DOI: https://doi.org/10.5731/pdajpst.2022.012810
Alfred Haglind
Cytiva, Bjorkgatan 30, 75323 Uppsala, Sweden
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  • For correspondence: alfred.haglind@cytiva.com
Emil Håkansson
Cytiva, Bjorkgatan 30, 75323 Uppsala, Sweden
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Nils Wallménius
Cytiva, Bjorkgatan 30, 75323 Uppsala, Sweden
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Annelie Hansson
Cytiva, Bjorkgatan 30, 75323 Uppsala, Sweden
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Karin Isaksson
Cytiva, Bjorkgatan 30, 75323 Uppsala, Sweden
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PDA Journal of Pharmaceutical Science and Technology: 78 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 6
November/December 2024
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Leachables Analysis from a Closed Connected Single-Use mAb Purification Process
Alfred Haglind, Emil Håkansson, Nils Wallménius, Annelie Hansson, Karin Isaksson
PDA Journal of Pharmaceutical Science and Technology Nov 2024, 78 (6) 643-680; DOI: 10.5731/pdajpst.2022.012810

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Leachables Analysis from a Closed Connected Single-Use mAb Purification Process
Alfred Haglind, Emil Håkansson, Nils Wallménius, Annelie Hansson, Karin Isaksson
PDA Journal of Pharmaceutical Science and Technology Nov 2024, 78 (6) 643-680; DOI: 10.5731/pdajpst.2022.012810
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Keywords

  • Extractables and leachables
  • Leachable screening
  • mAb
  • Biomanufacturing
  • Extractables and leachables testing
  • Single-use bioreactor

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