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Research ArticleResearch

A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool

Mingyang Hei, Qingqing She, Quanmin Chen, Zhaowei Jin, Chunmeng Sun, Jiasheng Tu and Jeremy Guo
PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 157-169; DOI: https://doi.org/10.5731/pdajpst.2023.012867
Mingyang Hei
1Technology Transfer Center of Excellence, Drug Product Development Department, WuXi Biologics, 299 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, China, 200131; and
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Qingqing She
1Technology Transfer Center of Excellence, Drug Product Development Department, WuXi Biologics, 299 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, China, 200131; and
2State Key Laboratory of Natural Medicines, NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, and Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, 20 Tong Jia Xiang, Nanjing, China, 210009
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Quanmin Chen
1Technology Transfer Center of Excellence, Drug Product Development Department, WuXi Biologics, 299 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, China, 200131; and
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Zhaowei Jin
1Technology Transfer Center of Excellence, Drug Product Development Department, WuXi Biologics, 299 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, China, 200131; and
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Chunmeng Sun
2State Key Laboratory of Natural Medicines, NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, and Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, 20 Tong Jia Xiang, Nanjing, China, 210009
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Jiasheng Tu
2State Key Laboratory of Natural Medicines, NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, and Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, 20 Tong Jia Xiang, Nanjing, China, 210009
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Jeremy Guo
1Technology Transfer Center of Excellence, Drug Product Development Department, WuXi Biologics, 299 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, China, 200131; and
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  • For correspondence: Jeremy_guo@wuxibiologics.com
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PDA Journal of Pharmaceutical Science and Technology: 79 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 2
March/April 2025
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A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
Mingyang Hei, Qingqing She, Quanmin Chen, Zhaowei Jin, Chunmeng Sun, Jiasheng Tu, Jeremy Guo
PDA Journal of Pharmaceutical Science and Technology Mar 2025, 79 (2) 157-169; DOI: 10.5731/pdajpst.2023.012867

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A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
Mingyang Hei, Qingqing She, Quanmin Chen, Zhaowei Jin, Chunmeng Sun, Jiasheng Tu, Jeremy Guo
PDA Journal of Pharmaceutical Science and Technology Mar 2025, 79 (2) 157-169; DOI: 10.5731/pdajpst.2023.012867
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Keywords

  • Peristaltic pump
  • Filling volume variability
  • Filling accuracy
  • High concentration/viscosity filling
  • Filling accuracy optimization

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