New - Biopharma Quality Control : Residual Host DNA Testing
Residual Host Cell DNA Testing
Detection of residual host cell DNA by dPCR with MiQuant® Residual DNA E. coli, CHO or HEK-293 - dPCR Kits.
- Novel rapid, robust and sensitive method
- Fast workflow as no sample preparation is required prior to PCR analysis
- Meets EP, WHO and FDA criteria
- Compatible with QIAcuity®, ddPCR™, Quantstudio™ Absolute Q™
- Lyophilized kit components simplify logistics and storage
Residual host cell DNA testing is a critical aspect of quality
control in the production of biopharmaceuticals, including recombinant
proteins, monoclonal antibodies, and cell-based therapies. Host cell DNA
refers to the genetic material originating from the cell line used to
produce the biopharmaceutical product. For this purpose, CHO, HEK-293
and E. coli cells are frequently used. Even after extensive downstream
purification processes, trace amounts of residual host cell DNA may
remain in the final product, posing potential safety and regulatory
concerns.
The WHO, FDA, and the European Pharmacopoeia recommend that the
residual DNA concentration is less than 10 ng/dose in the final product.
Minerva Biolabs has developed a digital PCR assay for the detection
of residual host cell DNA for E.coli, CHO or HEK-293 - MiQuant® Residual
DNA dPCR. The use of dPCR reduces time-to-result since no sample
preparation is required prior to dPCR analysis and enables absolute
quantification without a standard curve. With the help of the dPCR
Validation Standards it is possible to determine a matrix-specific
conversion factor that converts [copies/µl] into [pg/µl] to provide a
quantification of the residual DNA in conformity to regulatory
guidelines.
Short multicopy targets in the CHO (repeated element, ~ 1 million
copies per genome), E. coli (7 genome copies), and HEK-293 (repeated
element, ~ 1 million copies per genome) genomes are amplified. The
length of the amplicons is < 200 bp and, therefore, short enough to
allow the amplification of highly degraded DNA according to guidelines.
dPCR Validation Standards
The dPCR Validation Standards contain pure, quantified genomic DNA of the selected species or cell lines. These products are designed as a tool to assist Residual DNA dPCR-based analysis.
Minerva Biolabs
Description
The
dPCR Validation Standards contain pure, quantified genomic DNA of the
selected species or cell lines. These products are designed as a tool to
assist Residual DNA dPCR-based analysis.
Recommended Use
Each dPCR Validation Standard can be applied to generate genomic DNA
Standard curves for the specific species or cell lines of interest, by
serial dilution. A standard curve can be used to convert the measured
DNA in copies/µl through dPCR in fg/µl to provide a quantification of
the residual DNA in conformity to regulatory guidelines. In addition,
the dPCR Validation Standards can be used during downstream processes to
verify the residual DNA concentration of the processed sample during
several purification processes.
Content
Each dPCR Validation Standard contains 1 vial containing 1 ng of
lyophilized genomic DNA and 1 vial of Rehydration Buffer. The expiry
date of the unopened package is given on the package label.
Available Species and Ordering Information
Cat. No. 58-0201: E. coli
Cat. No. 58-0211: CHO
Cat. No. 58-0221: HEK-293
Result Evaluation
These products are designed as a tool to assist Residual DNA dPCR-based analysis:
• MiQuant Residual DNA dPCR E. coli
• MiQuant Residual DNA dPCR CHO
• MiQuant Residual DNA dPCR HEK-293
Required Consumables
1.5 ml reaction tubes, DNA- and RNA-free
Required Lab Devices
• Pipettes with corresponding filter tips (10 and 100 μl)
• Microcentrifuge for 1.5 ml reaction tubes
• Vortex
Shelf Life and Storage
The components must be stored at 2 °C to 8 °C until use. Once
rehydrated, the dPCR Validation Standards can be stored at ≤ -18 °C for a
maximum of 30 days. Repeated freeze-thaw cycles must be avoided.
If you cannot find the answer to your problem then please contact us or telephone +44 (0)1954 210 200