Compositions and methods for detecting biological contaminants

CN114875175BActive Publication Date: 2025-04-15REGENERON PHARMACEUTICALS INC
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Patent Information

Application Number
CN202210143904.4
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2015-03-27
Filing Date
2016-03-25
Publication Date
2025-04-15
Estimated Expiration
2036-03-25

AI Technical Summary

Technical Problem

The prior art is difficult to distinguish in real time whether the positive Q-PCR signal of the target contaminant in a test sample is true or false positive, especially when detecting biological contaminants in cell cultures.

Method used

The positive amplification control (PAC) plasmid containing the target sequence of the biological contaminant and the specific artificial plasmid-specific sequence was used to detect the specific artificial plasmid-specific sequence of the positive control through a unique detection probe to determine the authenticity of the results.

Benefits of technology

The rapid and accurate distinction between true and false positive results in cell culture is achieved, reducing the costly corrective measures caused by false positives.

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Abstract

Provided herein are compositions and methods for determining whether microbial contaminants are present in a biotherapeutic manufacturing process. Specifically, provided are artificial positive amplification control plasmids and unique quantitative PCR detection probes that enable rapid and real-time detection of false positive results.
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Citation Information

Patent Citations

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