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Research ArticleTechnology/Application

Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System

Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660
Natraj Ram
1Thermo Fisher Scientific;
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Jeff Johnson
2Biotech Design LLC;
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Hiren Ardeshna
3GlaxoSmithKline plc;
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Joseph Camire
1Thermo Fisher Scientific;
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Ryan Campbell
4Rockwell Automation;
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Doan Chau
4Rockwell Automation;
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Sam Gardner
5Merck and Company;
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Kevin Gibson
6PM Group;
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Joey Norikane
7National Institute for Innovation in Manufacturing Biopharmaceuticals; and
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Paul Randolph
8Janssen
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Kelly Smith
1Thermo Fisher Scientific;
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Katherine Stafford
1Thermo Fisher Scientific;
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Rachel Swamy
7National Institute for Innovation in Manufacturing Biopharmaceuticals; and
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Shana Usery
1Thermo Fisher Scientific;
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Kelvin H. Lee
7National Institute for Innovation in Manufacturing Biopharmaceuticals; and
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  • For correspondence: KHL@udel.edu
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References

  1. 1.↵
    BioPhorum. NIIMBL-BioPhorum Buffer Stock Blending System: A More Advanced Concept for Buffer Manufacturing. 2019. https://www.biophorum.com/wp-content/uploads/bp_downloads/NIIMBL-BioPhorum-buffer-stock-blending-system_-a-more-advanced-concept-for-buffer-manufacturing-December-2019.pdf
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    GE Healthcare. Single-Use Technology and Sustainability: Quantifying the Environmental Impact in Biologic Manufacturing. 2017. https://cdn.cytivalifesciences.com/dmm3bwsv3/AssetStream.aspx?mediaformatid=10061&destinationid=10016&assetid=16801
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    1. Mantle J. L.,
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  12. 12.↵
    BioPhorum. An Economic Evaluation of Buffer Preparation Philosophies for the Biopharmaceutical Industry; 2019. https://www.biophorum.com/wp-content/uploads/bp_downloads/An-economic-evaluation-of-buffer-preparation-philosophies-for-the-biopharmaceutical-industry-December-2019.pdf
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    1. Goklen K. E.,
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    Buffer System for Protein Purification. US Patent 9,624,261 B2, 2017.
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    The Environmental Impact of Disposable Technologies. BioPharm Int. 2008, 21 (11 Suppl), 4–15.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 77 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 2
March/April 2023
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Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery, Kelvin H. Lee
PDA Journal of Pharmaceutical Science and Technology Mar 2023, 77 (2) 79-98; DOI: 10.5731/pdajpst.2021.012660

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Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery, Kelvin H. Lee
PDA Journal of Pharmaceutical Science and Technology Mar 2023, 77 (2) 79-98; DOI: 10.5731/pdajpst.2021.012660
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Keywords

  • Buffer manufacture
  • buffer stock blending
  • in-line conditioning
  • cGMP
  • open-source skid

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