In the production of biotherapeutics, it is crucial to reduce the levels of residual host cell DNA to prevent the introduction of extraneous genetic material into patients. The amount of host cell DNA in drug substances should be limited to a range of 10–100 pg/dose, depending on the specific cell line and dosing regimen. Probe-based DNA quantification is a validated and recommended method for evaluating recombinant therapeutics derived from E. coli or CHO cells, as it ensures high sensitivity and accuracy.
Yeasen's Host Cell DNA Quantification Kits provide innovative solutions for precisely detecting residual host cell DNA in bioprocessing intermediates or final pharmaceutical products.
