Detection of multiple specific adventitious viruses in viral gene therapy products using multiplex PCR coupled with capillary electrophoresis

Guangyu Wang; Lingli Xu; Lei Yu; Xinchang Shi; Xi Qin; Yong Zhou

doi:10.1016/j.jpha.2024.101096

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Guangyu Wang, Lingli Xu, Lei Yu, Xinchang Shi, Xi Qin, Yong Zhou. Detection of multiple specific adventitious viruses in viral gene therapy products using multiplex PCR coupled with capillary electrophoresis[J]. Journal of Pharmaceutical Analysis. doi: 10.1016/j.jpha.2024.101096

Citation:

Guangyu Wang, Lingli Xu, Lei Yu, Xinchang Shi, Xi Qin, Yong Zhou. Detection of multiple specific adventitious viruses in viral gene therapy products using multiplex PCR coupled with capillary electrophoresis[J]. Journal of Pharmaceutical Analysis. doi: 10.1016/j.jpha.2024.101096

Citation:

Guangyu Wang, Lingli Xu, Lei Yu, Xinchang Shi, Xi Qin, Yong Zhou. Detection of multiple specific adventitious viruses in viral gene therapy products using multiplex PCR coupled with capillary electrophoresis[J]. Journal of Pharmaceutical Analysis. doi: 10.1016/j.jpha.2024.101096

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Detection of multiple specific adventitious viruses in viral gene therapy products using multiplex PCR coupled with capillary electrophoresis

doi: 10.1016/j.jpha.2024.101096

a. National Institutes for Food and Drug Control, Beijing, 100050, China;
b. Danaher Life Sciences China, Shanghai, 200335, China

Funds:

This work was financially supported by Beijing Municipal Science &

Technology Commission （Z221100007922015）and Youth Development Research Foundation of NIFDC(2020B1)

Received Date: Jan. 31, 2024
Accepted Date: Sep. 02, 2024
Rev Recd Date: Aug. 02, 2024
Available Online: Sep. 06, 2024

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References

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[2]	C. Morris, Y. Lee, S. Yoon, Adventitious agent detection methods in bio-pharmaceutical applications with a focus on viruses, bacteria, and mycoplasma, Curr. Opin. Biotechnol, 71(2021) 105-114.
[3]	D. Jacob, U. Sauer, R. Housley, et al., Rapid and high-throughput detection of highly pathogenic bacteria by Ibis PLEX-ID technology, PLoS. One. 7(2012), e39928.
[4]	S. Gardner, C. Jaing, K. McLoughlin, et al., A microbial detection array (MDA) for viral and bacterial detection, BMC. Genomics. 25(2010) ,668.
[5]	A. Simmons, K. Jantz, Use of a lentivirus/VSV pseudotype virus for highly efficient genetic redirection of human peripheral blood lymphocytes, Nat. Protoc. 1(2006) 2688-2700.