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The Vero cell line is a commonly used immortalized cell line in viral vaccine production. Residual DNA from host cells poses risks of infectivity, immunogenicity, or carcinogenicity. The maximum acceptable level of residual DNA is 10 ng/dose, while the requirement for DNA fragment size is smaller than the length of a functional gene (the minimum length of a functional gene is 200 bp). Fragments larger than 200 bp carry greater potential risks, making it essential for vaccine manufacturers to test the size distribution of residual DNA fragments in finished products.
Junyan Biotech’s independently developed Vero residual DNA fragment (qPCR) detection kit is used to quantitatively analyze the size distribution of Vero host cell DNA residual fragments in intermediate, semi-finished, and finished biological products. Based on the principle of PCR fluorescent probe technology, the kit designs four different amplified fragments (86 bp, 154 bp, 242 bp, 540 bp) to rapidly and specifically detect DNA fragment distribution. It can be used in conjunction with our company’s host residual DNA sample pretreatment kit.
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