Safety Monitoring

Evaluation of carbon dioxide signal based rapid microbiological method for sterility testing of cell preparations*

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  • 1. Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China;
    2. Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Quality Analysis of Chemical Drug Preparations, Shanghai 201203, China

Revised date: 2021-10-15

  Online published: 2024-06-21

Abstract

Objective: To evaluate feasibility of the BacT/ALERT 3D Dual-T rapid microbial detection system based on carbon dioxide signal detection technology as an alternative to the pharmacopoeia sterility test for innovative biologics. Methods: Taking cell products as the application object and referring to pharmacopoeia and foreign guidelines, whether the pharmacopoeia method could be replaced with the rapid method in terms of specificity, LOD and non-inferiority. Results: The evaluation results show that the rapid method was equivalent to the pharmacopoeia method in terms of specificity and detection limit parameters; in most cases, it could report positive results faster than the pharmacopoeia method. The rapid method was not inferior to the compendial method in product quality decision-making, and had advantages in terms of data integrity. Conclusion: Under the premise of risk management, the proven rapid microbiological method can be used as an alternative method to pharmacopoeia sterility testing for rapid release of innovative biologics..

Cite this article

LI Gao-min, PAN Wei-jing, WANG Can, CHEN Gang, SHAO Hong . Evaluation of carbon dioxide signal based rapid microbiological method for sterility testing of cell preparations*[J]. Chinese Journal of Pharmaceutical Analysis, 2022 , 42(1) : 147 -155 . DOI: 10.16155/j.0254-1793.2022.01.17

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