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OtherTechnology/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 August 2022, pdajpst.2021.012660; DOI: https://doi.org/10.5731/pdajpst.2021.012660
Natraj Ram
1 Thermo Fisher Scientific;
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Jeff Johnson
2 Biotech Design LLC;
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  • For correspondence: biotechdesign@outlook.com
Hiren Ardeshna
3 GlaxoSmithKline plc;
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Joseph Camire
1 Thermo Fisher Scientific;
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Ryan Campbell
4 Rockwell Automation;
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Doan Chau
4 Rockwell Automation;
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Sam Gardner
5 Merck and Company;
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Kevin Gibson
6 PM Group;
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Joey Norikane
7 National Institute for Innovation in Manufacturing Biopharmaceuticals;
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  • For correspondence: jnorikan@udel.edu
Paul Randolph
8 Janssen;
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Kelly Smith
1 Thermo Fisher Scientific;
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Katherine Stafford
1 Thermo Fisher Scientific;
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Rachel Swamy
7 National Institute for Innovation in Manufacturing Biopharmaceuticals;
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Shana Usery
1 Thermo Fisher Scientific;
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  • For correspondence: shana.usery@thermofisher.com
Kelvin H. Lee
9 University of Delaware
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Abstract

Buffer solutions are a critical component of the manufacturing process for therapeutic proteins and other biomolecules. The traditional way to make and use buffers is space and resource intensive, creating operational bottlenecks that impact efficiencies and costs. Here we describe a full scale, current Good Manufacturing Practices (cGMP) capable buffer stock blending system that has an open-source, configurable design and that overcomes the challenges of traditional buffer preparation. The system comprises simplified control and operation using mass flow to provide on-demand supply of buffer solutions. The system also has self-cleaning capability and is amenable to be operated as a closed system. The data will demonstrate the excellent performance and capabilities of the system as well as illustrate its potential transformative impact on biomanufacturing.

  • Buffer manufacture
  • Buffer stock blending
  • cGMP
  • in-line conditioning
  • open-source skid
  • Received June 22, 2021.
  • Accepted July 29, 2022.
  • Copyright © 2022, Parenteral Drug Association
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PDA Journal of Pharmaceutical Science and Technology: 77 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 1
January/February 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 Aug 2022, pdajpst.2021.012660; 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 Aug 2022, pdajpst.2021.012660; DOI: 10.5731/pdajpst.2021.012660
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Keywords

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

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