This 3rd generation CHO HCP ELISA kit 3G, item number F550-1, will replace the current CHO HCP ELISA kit, 3G, item number F550. Cygnus has manufactured, characterized, and qualified large groups of new reagents that will replace current reagents. Antibodies were developed and purified in the same manner as the original critical reagents of the F550 kit. The coverage of the new antibodies against the CHO HCP antigen from the CHO-S and CHO-K1 strains was determined to be ~86% by antibody affinity extraction, which is not significantly different from the current antibodies in the F550 kit.
More importantly, Cygnus Technologies has demonstrated the equivalence of the new antibodies (3G-0016-1-AF) in the 3G CHO ELISA (F550-1) using a panel of CHO samples from several independent biomanufacturing processes. Similar to the F550 “CHO 3G” ELISA, the F550-1 “CHO 3G” ELISA is more sensitive than previous kits, capable of detecting HCPs in the 100 parts per billion range for a variety of antibodies and other proteins. therapeutics expressed in CHO.
These data indicate that the kit is truly a generic method that can likely be validated not only as a process development tool but in most cases as a batch release test, thus eliminating the need to develop an essay. custom or process specific. This new CHO HCP ELISA kit from Cygnus Technologies, 3G, provides the specificity and sensitivity (LOD ~0.3 ng/mL, LLOQ ~1 ng/mL) to detect HCP with reproducibility that supports regulatory compliance. Use Sample Diluent, Item # I028, with these kits; available separately.
Product Type: ELISA Kit
Storage: All kit reagents 2°C to 8°C
Target expression system: CHO
Species group: mammal
Species: Chinese hamster
Assay format: 96-well plate
Time to result: ~2 hrs. 50 minutes
LLOQ: ~1 ng/mL
Recommended thinner: I028