Residual Host Cell DNA Testing

Detect residual host-cell DNA using digital PCR with the MiQuant® Residual DNA – dPCR Kits.

• Robust and highly sensitive
• Fast workflow without prior DNA extraction
• Meets the requirements of the Ph. Eur., WHO, and FDA
• Compatible with QIAcuity®, ddPCR™, and Quantstudio™ Absolute Q™
• Lyophilized kit components simplify shipping and storage

Testing for residual host-cell DNA is an important aspect of quality control in the manufacture of biopharmaceuticals, including recombinant proteins, monoclonal antibodies, and cell-based therapies. Host-cell DNA is defined as genetic material originating from the cell line used to manufacture the biopharmaceutical product. Commonly used production systems include CHO, HEK-293, and E. coli cells. Even after extensive purification, traces of residual host-cell DNA may remain in the final product, potentially raising safety and regulatory concerns.

The WHO, FDA, and European Pharmacopoeia recommend that the residual DNA content in the final product should be below 10 ng per dose.

Minerva Biolabs has developed digital PCR assays for the detection and quantification of residual host-cell DNA. Digital PCR enables direct sample analysis without prior DNA extraction and provides absolute quantification without requiring a standard curve. The dPCR Validation Standards can be used to determine a matrix-specific conversion factor for converting results from [copies/µl] to [fg/µl], supporting residual DNA quantification in accordance with 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.