MiQuant® Residual DNA HEK-293 – dPCR
Digital PCR assay for the quantitative determination of residual host cell DNA from HEK-293 cells.
- Direct testing without DNA extraction
- Meets EP, WHO, and FDA criteria
- Universally compatible with dPCR and ddPCR™ platforms
Cat. no.: 58-0121
$340.00
Tax excluded
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Validation Report
Validation Report for MiQuant® Residual DNA HEK-293 – dPCR
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Product Description
HEK-293 cells are established production cell lines for viral vectors and recombinant proteins, particularly in cell and gene therapy. Residual HEK-293 DNA is considered a process-related impurity and must be reliably quantified and controlled throughout the manufacturing process.
MiQuant® Residual DNA HEK-293 - dPCR is a digital PCR assay for the quantitative determination of residual HEK-293 DNA in chemical and biological matrices. The assay was developed for research and quality control in biopharmaceutical manufacturing processes.
Samples can be analyzed directly without prior DNA extraction. This reduces the total workflow to less than three hours and prevents potential DNA loss during purification.
A short multicopy target sequence within the HEK-293 genome enables the sensitive detection of highly fragmented or degraded HEK-293 DNA. The assay supports the quantification requirement of 10 fg/µl in the test sample described in Ph. Eur. 2.6.35.
Digital PCR enables direct sample analysis without prior DNA extraction. It also allows absolute quantification without the need for a standard curve. Using the dPCR Validation Standard HEK-293, a matrix-specific conversion factor can be determined to convert [copies/µl] into [fg/µl], enabling the quantification of residual DNA in accordance with applicable regulatory guidelines.
Specifications
| Application | Quantification of residual DNA from HEK-293 host cells |
|---|---|
| Application areas |
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| Contents |
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| Compliance | EP 2.6.35, WHO, FDA |
| Validation report | available |
| Time-to-result | < 3 h |
| PCR type |
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| Compatible devices | QIAcuity®, Quantstudio™ Absolute Q™, QX200™/QX600™ ddPCR™ |
| Detection limit (LOD) | ≤ 0.04 fg/μl |
| Target | Human Embryonic Kidney |
| Control system |
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| Number of reactions |
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| Price per reaction |
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| Required equipment and consumables |
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| Storage | 2-8 °C; ≤ –18 °C after rehydration |
| Shipping | Ambient temperature |
| Shelf life (max.) | 18 months |
Regulatory Disclaimer
For research and industrial use only. Not for diagnostic or therapeutic use.
Minerva Biolabs offers a free sample of this product for testing:
Request free sample