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

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 and Xiaolin Cao

PDA Journal of Pharmaceutical Science and Technology May 2024, pdajpst.2023.012894; DOI: https://doi.org/10.5731/pdajpst.2023.012894

Bo Wang

WuXi Biologics

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Shanshan Zhang

WuXi Biologics

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Mengyi Chen

WuXi Biologics

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Ming Lei

WuXi Biologics

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Tian Gao

WuXi Biologics

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Wei Fan

WuXi Biologics

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Jincui Huang

WuXi Biologics

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Xiaolin Cao

WuXi Biologics

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For correspondence: cao_xiaolin@wuxibiologics.com

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pdajpst.2023.012894

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

Received September 5, 2023
Accepted May 7, 2024
Published online May 31, 2024.

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Bo Wang,
Shanshan Zhang,
Mengyi Chen,
Ming Lei,
Tian Gao,
Wei Fan,
Jincui Huang and
Xiaolin Cao 1 (cao_xiaolin{at}wuxibiologics.com)

WuXi Biologics

↵* Corresponding author; email: cao_xiaolin{at}wuxibiologics.com

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 1

January/February 2025

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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 May 2024, pdajpst.2023.012894; 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 May 2024, pdajpst.2023.012894; DOI: 10.5731/pdajpst.2023.012894

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Keywords

Extrinsic particles
Inherent particles
Intrinsic particles
Particle identification
Root cause analysis
Visible particles

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