Biosimilar QC teams run the same problem every week. Complex in-process samples carry proteins, salts, and debris that destroy qPCR sensitivity. You add the sample straight to the reaction and the signal scatters.
Extraction is the fix.
It removes the junk before quantification starts.
DeQuanto®️ extraction kits use a magnetic bead system for both CHO and E. coli samples. The workflow is the same simple sequence that labs actually run.
You start with your process or API sample.
Run the lysis step.
Magnetic beads bind the DNA.
Two washes remove the remaining contaminants.
Final elution gives you clean material ready for downstream qPCR.
This approach handles the matrix challenges that stop most kits. It delivers DNA clean enough for accurate quantification in real biosimilar workflows.
Why is this important?
USP General Chapter <509> Residual DNA Testing is clear. Effective extraction is required before qPCR to minimise matrix effects in products made in CHO or E. coli cells. The chapter emphasises validated sample preparation to ensure reliable measurement against the ≤10 ng per dose limit set by WHO and FDA guidelines.
Skip this step, and your data risks failing system suitability. Run it properly, and the entire quantification process becomes more robust.
High-level workflow that works for both cell lines
- Lysis step on the sample
- Magnetic bead binding of DNA
- Two washes to clear contaminants
- Elution in nuclease-free water
The same protocol serves both CHO and E. coli processes. No need to switch kits or retrain the team when you move between projects.
What it means for labs?
- Cleaner input for qPCR reduces failed runs.
- Faster turnaround keeps biosimilar filing schedules on track.
- Consistent results across different sample types.
Download the free Extraction Workflow Checklist
We put together a one-page reference that QC teams use to run the steps without missing details. It covers the sequence, key checkpoints, and common matrix pitfalls.
Once extraction is done right, quantification becomes straightforward.
The data you get actually reflects the process performance instead of fighting the sample itself.
What matrix gives your team the biggest headache right now?
Drop it in the comments below.