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Updated: Aug 23, 2026
A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears
Published on: July 14, 2023
[Quality control of clinical-grade recombinant adenovirus used in gene therapy]
Xiao-zhi Zhang1, Hong Lin, Xiao-yan Yang
1Shenzhen SiBiono GeneTech Co. Ltd, Shenzhen 518057, China.
Objective:
To establish the quality control methods and reference standards for clinical-grade recombinant adenovirus products for human gene therapy.
Methods:
The Infectivity of clinical grade recombinant adenoviral vectors is determined by a TCID(50) assay. The purity is determined by a high-performance liquid chromatography (HPLC) assay. A549 cells were used in replication competent adenovirus (RCA) assay of samples by observation of the cytopathic effect. Other quality control assays were performed in accordance with the SFDA Regulations for Biological Products.
Results:
The recombinant adenovirus encoding human p53 gene produced at SiBiono (Lot 20010701) has the following quality attributes: viral particle concentration: 1.03 (10(12) VP/ml, infectivity titer: 5.01 (10(10) IU/ml, specific infectivity (IU/VP): 4.86%, higher than the 3.3% required by the Food and Drug Administration (FDA), USA; Purity by HPLC analysis: 98.62%, higher than the 95% purity specified by SFDA; and level of RCA: less than 1 RCA/3 (10(10) VP, meeting the standards established by SFDA.
Conclusions:
A whole set of quality standards of clinical-grade recombinant adenovirus vectors has been established so as to ensure the clinical safety and efficacy of recombinant adenoviral vectors for human gene therapy.
