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It is possible to achieve high sensitivity and rapid detection of viruses as described in the law concerning the assurance of safety in regenerative medicine and other related fields!
The gene detection kit VirFinder for virus denial testing can detect eight types of viruses listed in the law concerning the assurance of safety in regenerative medicine and other fields.
Contributing to cell safety!
Aseptic testing is generally required to be conducted using the final processed product as the test specimen, based on the aseptic testing method specified in the Japanese Pharmacopoeia General Test Method (4.06). This testing method requires a culture period of more than 14 days to obtain results. On the other hand, for specific cell processing products, it is desirable to obtain the results of the aseptic test before administration to the patient. However, due to the time required to obtain results from the pharmacopoeia-compliant aseptic test, it is often the case that test results are determined after administration. Additionally, for specific cell processing products, due to limitations such as the amount of specimen available and the time required for testing, it may not be possible to apply the aseptic testing method compliant with the pharmacopoeia. In such cases, consideration may be given to the "Rapid Microbial Testing Method" (as referenced in the 18th revision of the Japanese Pharmacopoeia). Our company has developed a rapid aseptic testing method using PCR that covers a wide range of microorganisms, including not only those listed in the pharmacopoeia but also environmental bacteria and human-derived bacteria, allowing for detection in a short time.
