MDCK Residual DNA (qPCR) Detection Kit

MDCK cells are passaged cells of a dog kidney cell line, mainly used for propagating cell-based seasonal influenza vaccines. This cell line has many advantages, such as high viral infection efficiency, fast proliferation, and resistance to mutation. MDCK cell lines are currently recognized as one of the most suitable cell lines for the production of influenza A and B virus vaccines. Although most residual DNA in host cells can be removed during the production of MDCK cell-based influenza vaccines through methods such as ultrafiltration, nuclease treatment, chromatography, and β - propiolide inactivation, there may still be residual DNA fragments in vaccine products. Therefore, in order to control the quality of vaccine production, it is necessary to monitor the residual DNA of MDCK host cells in vaccines. Various countries have also made relevant regulations on the residual DNA of host cells. The current guidelines of WHO and the US FDA recommend that the residual DNA in finished products should not exceed 10 ng/dose and the length should not exceed 200 bp. The guidelines issued by the US FDA state that the residual limit of host cell DNA in biological products is 100 pg/dose. For high-dose biological products such as monoclonal antibodies, the residual DNA content can be relaxed to 10 ng/dose based on their source of residual DNA and administration route. The limit of residual DNA in biological products stipulated by the General Principles of the European Pharmacopoeia is mostly not more than 10 ng/dose, but the limit standards for residual DNA in individual vaccines are stricter, such as the DNA residue in inactivated hepatitis A vaccines should not exceed 100 pg/dose, and the DNA residue in hepatitis B vaccines should not exceed 10 pg/dose. 

 The MDCK cell residual DNA (qPCR) detection kit independently developed by BioDomi GmbH can quickly and accurately quantify MDCK residual DNA in intermediate, semi-finished, and finished products of various viral vaccines and other biological products. The linear range of the reagent kit is 300pg/µ L~0.003pg/µ L. This reagent kit can be used in conjunction with BioDomi GmbH's "Host Cell Residual DNA (Magnetic Bead Method) Sample Preparation Kit" and fully automatic nucleic acid extraction instrument.

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