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MiQuant® Residual DNA CHO – dPCR
Digital PCR assay for the quantitative determination of residual host cell DNA from CHO cells.
- Direct testing without DNA extraction
- Meets EP, WHO, and FDA criteria
- Universally compatible with dPCR and ddPCR™ platforms
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Validation Report
Validation Report for MiQuant® Residual DNA CHO – dPCR
Validation Reports can only be requested by email.
Please contact us via:
support@minerva-biolabs.com
Thank you
Product Description
CHO cells are established production cell lines for recombinant biopharmaceuticals, such as monoclonal antibodies and therapeutic proteins. Residual CHO DNA is considered a process-related impurity and must be reliably quantified and controlled throughout the manufacturing process.
WHO and FDA guidelines define 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 CHO - dPCR is a digital PCR assay for the quantitative determination of residual CHO 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.
By amplifying a short multicopy target sequence within the CHO genome, the assay enables the sensitive detection of highly fragmented or degraded CHO 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. It also allows absolute quantification without the need for a standard curve. Using the dPCR Validation Standard CHO, 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 CHO 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 | Chinese Hamster Ovary |
| 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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