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Bacterial DNA (qPCR) Detection Kit
Product Introduction
With the rapid development of biomedical technology, the variety of ATMPs (Advanced Therapy Medicinal Products) is increasing. These drugs are mainly used in cell, gene, or tissue engineering therapies. Numerous studies and cases have shown that cell therapy drugs are prone to microbial contamination such as bacteria, fungi, and mycoplasma during production. Such microbial contamination can, to a certain extent, pose potential risks to patients. Therefore, sterility testing is required in the production of cell-based biological products. Currently, sterility testing has become one of the most important quality control items for cell-based products and runs through the entire production process of cell-based products.
This kit can be used for rapid qualitative detection of bacterial contamination in cells, vaccines, gene therapy products, and other biological products. It is used in conjunction with Junyan Bio's Bacterial & Fungal DNA (Magnetic Bead Method) Extraction and Purification Kit.
This kit can cover 60,000 species (subspecies) of bacteria. For the detection of eight common strains (Staphylococcus aureus, Bacillus subtilis, Salmonella paratyphi B, Clostridium sporogenes, Escherichia coli, Pseudomonas aeruginosa, Streptococcus pyogenes, Propionibacterium acnes), the limit of detection can reach 50-100 CFU/reaction, meeting the sterility requirements of the Chinese Pharmacopoeia.
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