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.
Products