Development and Validation of a Quantitative LC-MS/MS Method for Measuring CYP4V2 Enzyme Activity via 12-Hydroxylauric Acid in rAAV-hCYP4V2 Gene Therapy Products.

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Title: Development and Validation of a Quantitative LC-MS/MS Method for Measuring CYP4V2 Enzyme Activity via 12-Hydroxylauric Acid in rAAV-hCYP4V2 Gene Therapy Products.
Authors: Ren G; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China.; School of Life and Health Sciences, Hubei University of Technology, Wuhan 430068, China., Qin X; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China., Li Y; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China., Fan W; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China., Luo W; Shanghai Vitalgen BioPharma Co., Ltd., Shanghai 201210, China., Cao Y; Shanghai Vitalgen BioPharma Co., Ltd., Shanghai 201210, China., Wang Y; School of Life and Health Sciences, Hubei University of Technology, Wuhan 430068, China., Zhou Y; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China., Liang C; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China.
Source: Molecules (Basel, Switzerland) [Molecules] 2026 Apr 24; Vol. 31 (9). Date of Electronic Publication: 2026 Apr 24.
Publication Type: Journal Article
Journal Info: Publisher: MDPI Country of Publication: Switzerland NLM ID: 100964009 Publication Model: Electronic Cited Medium: Internet ISSN: 1420-3049 (Electronic) Linking ISSN: 14203049 NLM ISO Abbreviation: Molecules Subsets: MEDLINE
Database: MEDLINE Ultimate
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ISSN:1420-3049
DOI:10.3390/molecules31091417