First WHO International Standard for Lentiviral Vectors

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iBET participated on a World Health Organization (WHO) collaborative study to produce the first International Standard for Lentiviral Vector (LV) integration copy number. WHO standard or reference materials are common tools in a variety of research areas such as vaccine, antibiotics, diagnostics and gene therapy enabling normalizing research results across laboratories. 

Since the number of clinical trials using LV for gene therapy is increasing, the WHO in collaboration with multiple companies, clinicians and the academic community enrol in the effort to develop standardized materials for LV research.

iBET researchers Sofia Fernandes and Ana Sofia Coroadinha contributed with the analysis and determination of the lentiviral vector integration copy numbers using two quantitative PCR based methods: TaqMan qPCR and SYBRGreen qPCR. Based on results from different laboratories, candidate reference materials of human genomic DNA containing (i) zero, (ii) low or (iii) high copies of integrated lentiviral vectors genomes were developed. 

This collaborative effort involving forty different institutions from 15 countries was approved during the 70th WHO Expert Committee on Biological Standardization and it will help fulfilling one of the objectives of WHO: improve global access to Advanced Therapy Medicinal Products (ATMPs).