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MDCK Cell Residual DNA (qPCR) Detection Kit
MDCK cells are a continuous cell line derived from dog kidney cells, primarily used for propagating cell-based seasonal influenza vaccines. This cell line offers numerous advantages, such as high viral infection efficiency, rapid proliferation, and low mutation rate. The MDCK cell line is currently recognized as one of the most suitable for producing influenza A and B virus vaccines. Although most host cell residual DNA can be removed during the production of MDCK cell-based influenza vaccines through methods such as ultrafiltration, nuclease treatment, chromatography, and β-propiolactone inactivation, DNA fragments may still persist in the vaccine products. Therefore, to control vaccine production quality, monitoring of MDCK host cell residual DNA in vaccines is required.
Regulatory authorities worldwide have established relevant guidelines for host cell DNA residues. Current guidelines from the WHO and FDA recommend that residual DNA in finished products should not exceed 10 ng/dose and should be no longer than 200 bp in length. FDA guidelines specify a residual host cell DNA limit of 100 pg/dose for biological products, while for high-dose biologicals such as monoclonal antibodies, the DNA residue limit may be relaxed to 10 ng/dose depending on the source of residual DNA and the route of administration. The European Pharmacopoeia generally sets the residual DNA limit for biological products at no more than 10 ng/dose, but stricter standards apply to specific vaccines—for example, the residual DNA limit for inactivated hepatitis A vaccine is ≤100 pg/dose, and for hepatitis B vaccine, it is ≤10 pg/dose.
The MDCK cell residual DNA (qPCR) detection kit independently developed by Junyan Biotech enables rapid and accurate quantification of MDCK residual DNA in intermediate, semi-finished, and finished products of various viral vaccines and other biologicals. The kit has a linear range of 300 pg/μL to 0.003 pg/μL. It can be used in conjunction with Junyan Biotech’s "Host Cell Residual DNA (Magnetic Bead Method) Sample Pretreatment Kit" and fully automated nucleic acid extractors.
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