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Research ArticleResearch

Identification and Root Cause Analysis of the Visible Particles Commonly Encountered in the Biopharmaceutical Industry

Bo Wang, Shanshan Zhang, Mengyi Chen, Ming Lei, Tian Gao, Wei Fan, Jincui Huang and Xiaolin Cao
PDA Journal of Pharmaceutical Science and Technology September 2024, 78 (5) 586-603; DOI: https://doi.org/10.5731/pdajpst.2023.012894
Bo Wang
Analytical Sciences, Biologics Development, WuXi Biologics, Shanghai, 230019 China
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Shanshan Zhang
Analytical Sciences, Biologics Development, WuXi Biologics, Shanghai, 230019 China
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Mengyi Chen
Analytical Sciences, Biologics Development, WuXi Biologics, Shanghai, 230019 China
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Ming Lei
Analytical Sciences, Biologics Development, WuXi Biologics, Shanghai, 230019 China
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Tian Gao
Analytical Sciences, Biologics Development, WuXi Biologics, Shanghai, 230019 China
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Wei Fan
Analytical Sciences, Biologics Development, WuXi Biologics, Shanghai, 230019 China
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Jincui Huang
Analytical Sciences, Biologics Development, WuXi Biologics, Shanghai, 230019 China
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Xiaolin Cao
Analytical Sciences, Biologics Development, WuXi Biologics, Shanghai, 230019 China
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  • For correspondence: cao_xiaolin@wuxibiologics.com
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Article Information

vol. 78 no. 5 586-603
DOI 
https://doi.org/10.5731/pdajpst.2023.012894
PubMed 
38824427

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 22, 2024.

Article Versions

  • previous version (May 31, 2024 - 08:05).
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Copyright & Usage 
© PDA, Inc. 2024

Author Information

  1. Bo Wang,
  2. Shanshan Zhangi,
  3. Mengyi Chen,
  4. Ming Lei,
  5. Tian Gao,
  6. Wei Fan,
  7. Jincui Huang and
  8. Xiaolin Cao*
  1. Analytical Sciences, Biologics Development, WuXi Biologics, Shanghai, 230019 China
  1. ↵* Corresponding Author: 400 Fute Middle Rd., Waigaoqiao Free Trade Zone, Shanghai, 230019 China; Telephone: 86-(21) 50519788; E-mail: cao_xiaolin{at}wuxibiologics.com
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PDA Journal of Pharmaceutical Science and Technology: 78 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 5
September/October 2024
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Identification and Root Cause Analysis of the Visible Particles Commonly Encountered in the Biopharmaceutical Industry
Bo Wang, Shanshan Zhang, Mengyi Chen, Ming Lei, Tian Gao, Wei Fan, Jincui Huang, Xiaolin Cao
PDA Journal of Pharmaceutical Science and Technology Sep 2024, 78 (5) 586-603; DOI: 10.5731/pdajpst.2023.012894

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Identification and Root Cause Analysis of the Visible Particles Commonly Encountered in the Biopharmaceutical Industry
Bo Wang, Shanshan Zhang, Mengyi Chen, Ming Lei, Tian Gao, Wei Fan, Jincui Huang, Xiaolin Cao
PDA Journal of Pharmaceutical Science and Technology Sep 2024, 78 (5) 586-603; DOI: 10.5731/pdajpst.2023.012894
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  • Article
    • Abstract
    • Introduction
    • Materials and Methods
    • Particle Identification and Root Cause Analysis
    • Conclusion
    • Conflict of Interest Declaration
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Keywords

  • Visible particles
  • Extrinsic particles
  • Intrinsic particles
  • Inherent particles
  • Particle identification
  • Root cause analysis
  • Optical microscopy
  • Infrared microscopy
  • Raman microscopy
  • Scanning electron microscopy
  • Energy dispersive X-ray spectroscopy
  • Elemental analysis

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