Microsart® Validation Standard Aspergillus fumigatus
Microsart® Validation Standard are used for validating robustness and sensitivity of NAT-based detection methods, to be used for contamination control of cell cultures, cell culture media components and cell culture derived biologicals like cell autologous transplants and ATMPs.
Item no.: SMB95-2039
Price: $405.00
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Choose your Microsart® Mycoplasma Validation and Sensitivity Standards
Microsart® Validation Standards are not infectious and therefore safe in use. They are titrated to 99 CFU/ml, the sensitivity limit for sterility tests according to European Pharmacopoeia (EP) 2.6.1 Sterility. The fungal strains used for the manufacture of Microsart® Validation Standard are low passage reference strains cultivated in suitable culture broth. The cultures are harvested in the early logarithmic phase of the growth to avoid an atypical high ratio of dead fungal cells as well as a high GC:CFU-ratio.
Brochure
Catalog
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Additional Required Components
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qPCR cycler
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PCR reaction tubes
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Centrifuge for 1.5 ml PCR tubes
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Pipettes
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Extraction Kit
- PCR kit
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qPCR cycler
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Detection MethodPCR
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SpeciesAspergillus fumigatus
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What you receive
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6 vials with 99 CFU lyophilized
- 2 vials negative control lyophilized
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6 vials with 99 CFU lyophilized
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ApplicationFungal Detection
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Pack Size6
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Regulatory RequirementsFor EP 2.6.1 and 2.6.27 compliant validation
Microsart® Validation Standard are used for validating robustness and sensitivity of NAT-based detection methods, to be used for contamination control of cell cultures, cell culture media components and cell culture derived biologicals like cell autologous transplants and ATMPs.
Microsart® Validation Standard are used for validating robustness and sensitivity of NAT-based detection methods, to be used for contamination control of cell cultures, cell culture media components and cell culture derived biologicals like cell autologous transplants and ATMPs.
Microsart® ATMP Extraction kit introduces a state-of-the-art (DNA-free) method for DNA extraction from cell cultures and cell culture derived biologicals, like autologous transplants and other advanced therapy medicinal products (ATMP), for subsequent DNA amplification via PCR (e.g. Microsart ATMP Bacteria and Fungi qPCR Kits).
Microsart® Validation Standard are used for validating robustness and sensitivity of NAT-based detection methods, to be used for contamination control of cell cultures, cell culture media components and cell culture derived biologicals like cell autologous transplants and ATMPs.
Microsart® Validation Standard are used for validating robustness and sensitivity of NAT-based detection methods, to be used for contamination control of cell cultures, cell culture media components and cell culture derived biologicals like cell autologous transplants and ATMPs.
Microsart® Validation Standard are used for validating robustness and sensitivity of NAT-based detection methods, to be used for contamination control of cell cultures, cell culture media components and cell culture derived biologicals like cell autologous transplants and ATMPs.
Microsart® Validation Standard are used for validating robustness and sensitivity of NAT-based detection methods, to be used for contamination control of cell cultures, cell culture media components and cell culture derived biologicals like cell autologous transplants and ATMPs.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^6 genome copies of a specific fungal species per vial.
Microsart® ATMP Bacteria kit is designed for the direct detection of bacteria in cellcultures, cell culture derived biologicals and ATMPs (e.g. autologous transplants),based on real-time PCR (qPCR).