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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleResearch

NIIMBL-Facilitated Active Listening Meeting between Industry and FDA Identifies Common Challenges for Adoption of New Biopharmaceutical Manufacturing Technologies

Jennifer L. Mantle and Kelvin H. Lee
PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 497-508; DOI: https://doi.org/10.5731/pdajpst.2019.011049
Jennifer L. Mantle
National Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE 19713
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Kelvin H. Lee
National Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE 19713
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  • For correspondence: khl@udel.edu
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Article Information

vol. 74 no. 5 497-508
DOI 
https://doi.org/10.5731/pdajpst.2019.011049
PubMed 
32467179

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 5, 2020.

Article Versions

  • previous version (May 28, 2020 - 09:03).
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Copyright & Usage 
© PDA, Inc. 2020

Author Information

  1. Jennifer L. Mantle and
  2. Kelvin H. Lee*
  1. National Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE 19713
  1. ↵*Corresponding Author: National Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE 19713; E-mail: khl{at}udel.edu
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    Annual Review of Chemical and Biomolecular Engineering 2022 13 1
  • An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US
    Adam C. Fisher, William Liu, Andreas Schick, Mahesh Ramanadham, Sharmista Chatterjee, Raphael Brykman, Sau L. Lee, Steven Kozlowski, Ashley B. Boam, Stelios C. Tsinontides, Michael Kopcha
    International Journal of Pharmaceutics 2022 622
  • Biomanufacturing readiness levels [BRL]—A shared vocabulary for biopharmaceutical technology development and commercialization
    Sandeep B. Kedia, Jeffrey C. Baker, Ruben G. Carbonell, Kelvin H. Lee, Christopher J. Roberts, John Erickson, John E. Schiel, Kelley Rogers, Gene Schaefer, Stefanie Pluschkell
    Biotechnology and Bioengineering 2022 119 12
  • Driving adoption of new technologies in biopharmaceutical manufacturing
    Gene Schaefer, John Balchunas, Timothy Charlebois, John Erickson, Roger Hart, Sandeep B. Kedia, Kelvin H. Lee
    Biotechnology and Bioengineering 2023 120 9
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PDA Journal of Pharmaceutical Science and Technology: 74 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 5
September/October 2020
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NIIMBL-Facilitated Active Listening Meeting between Industry and FDA Identifies Common Challenges for Adoption of New Biopharmaceutical Manufacturing Technologies
Jennifer L. Mantle, Kelvin H. Lee
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 497-508; DOI: 10.5731/pdajpst.2019.011049

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NIIMBL-Facilitated Active Listening Meeting between Industry and FDA Identifies Common Challenges for Adoption of New Biopharmaceutical Manufacturing Technologies
Jennifer L. Mantle, Kelvin H. Lee
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 497-508; DOI: 10.5731/pdajpst.2019.011049
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Keywords

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