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MiQuant® Residual DNA E. coli – dPCR
Digital PCR assay for the quantitative determination of residual host cell DNA from E. coli.
- Direct testing without DNA extraction
- Meets EP, WHO, and FDA criteria
- Universally compatible with dPCR and ddPCR™ platforms
Cat. no.: 58-0101
$240.00
Tax excluded
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Validation Report
Validation Report for MiQuant® Residual DNA E. coli – dPCR
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Product Description
Escherichia coli (E. coli) is one of the best-characterized and most widely used host organisms for the production of recombinant biopharmaceuticals, including therapeutic proteins and antibody fragments. Residual E. coli host cell DNA is considered a process-related impurity and must therefore be reliably controlled and quantified during biopharmaceutical manufacturing.
WHO and FDA guidelines recommend risk-based limits that depend, among other factors, on the cell substrate, route of administration, and the tumorigenic and oncogenic potential of the residual DNA. For certain parenterally administered products derived from non-tumorigenic cell lines, less than 10 ng of residual DNA per dose and DNA fragments of approximately 200 bp or smaller are used as reference values.
MiQuant® Residual DNA E. coli - dPCR is a digital PCR assay for the quantitative determination of residual E. coli DNA in chemical and biological matrices. The assay was developed for research and quality control applications in biopharmaceutical manufacturing processes.
Samples can be analyzed directly without prior DNA extraction. This reduces the total workflow time to less than three hours and prevents potential DNA loss during purification.
By amplifying a short target sequence that occurs multiple times within the E. coli genome, the assay enables sensitive detection of highly fragmented or degraded E. coli DNA. The assay achieves the quantification limit of 10 fg/µL described in Ph. Eur. 2.6.35.
Digital PCR enables direct sample analysis without prior DNA extraction and allows absolute quantification without the need for a standard curve. Using the dPCR Validation Standard E. coli, a matrix-specific conversion factor can be determined to convert [copies/µL] into [fg/µL], enabling residual DNA quantification in accordance with regulatory requirements.
Specifications
| Application | Quantification of residual DNA from E. coli 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) | 0.13 fg/μl |
| Target | Escherichia coli |
| 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:
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