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Fungal 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. The most notable features of ATMPs include strict requirements for biological activity, inability to undergo terminal sterilization，significant differences in filtration processes, low production volume, short drug validity period, and urgent clinical needs. 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. Sterility testing mainly includes detection of bacteria, fungi, and mycoplasma. This kit is mainly used for qualitative detection of fungal contamination in cells, vaccines, gene therapy products, and other biological products.
This kit can be used for rapid qualitative detection of fungal 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 5,000 species (subspecies) of fungi. For the detection of two fungal strains mentioned in the Chinese Pharmacopoeia (Aspergillus niger and Candida albicans), the limit of detection can reach 50-100 CFU/reaction, meeting the sterility requirements of the Chinese Pharmacopoeia.
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