Detection of residual host cell DNA by dPCR with MiQuant® Residual DNA dPCR kits for E. coli, CHO or HEK-293:
- Novel rapid, robust and sensitive method
- Samples can be tested without performing DNA extraction
- Meets EP, WHO and FDA criteria
- Designed for use with the QIAGEN® QIAcuity® dPCR system
- Aliquoted PCR mix ensures long-term stability
- Lyophilized kit components simplify logistics and storage
Background & Description
Chinese hamster ovary cells (CHO), E. coli, and human embryonic
kidney cells (HEK-293) have been widely used to manufacture recombinant
proteins for human therapeutic use. After the synthesis of such
immunotherapeutic or biosimilar, it is found that there could be some
residual presence of DNA from the host cell. The World Health
Organization (WHO), the Food and Drug Agency (FDA), and the European
Pharmacopoeia (EP) recommend that the residual DNA in a manufactured
final product needs to be less than 10 ng/dose. Even though downstream
purification processes remove host cell residual DNA traces from
products, testing for residual DNA is significant to ensure the
The use of digital PCR (dPCR) is a very efficient way to determine
the concentration of residual DNA in the final product. The MiQuant®
Residual DNA dPCR kits for CHO, E. coli, and HEK-293 are the most
accurate, efficient, and cost-effective way to analyze residual DNA in a
sample without DNA extraction.
The kits are designed for QIAGEN®s QIAcuity® dPCR system as a novel
rapid, robust, and sensitive method for absolute DNA quantification.
This technology reduces the time needed for testing to less than three
hours, including the dPCR sample preparation and thermocycling. Also,
using these kits increases sensitivity since no DNA is lost during the
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.
Moreover, each kit contains all the necessary PCR components,
including Taq polymerase, primers, and dNTPs in a lyophilized mix, the
Rehydration Buffer, dPCR Grade Water, and lyophilized Internal Control.
The Internal Control is very reliable and will indicate any false
negative result caused by PCR inhibition.