Description
This CHO HCP 3rd Generation ELISA Kit, Item Number F550-1 will be replacing the current CHO HCP ELISA Kit, 3G, Item Number F550. Cygnus has manufactured, characterized, and qualified large pools of the new reagents that will replace the current reagents. The antibodies were developed and purified in the same way as the original critical reagents in the F550 Kit. The coverage of the new antibodies to the CHO HCP antigen from 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 equivalency of the new antibodies (3G-0016-1-AF) in the 3G CHO ELISA (F550-1) using a panel of CHO samples from a number of independent biomanufacturing processes. Similar to the F550 "CHO 3G" ELISA, the F550-1 “CHO 3G” ELISA is more sensitive than previous kits, able to detect HCPs in the range of 100 parts per billion for a variety of antibodies and other therapeutic proteins expressed in CHO. This data indicates the kit is truly a generic method that can likely be validated as not only a process development tool, but in most cases as a lot release test, eliminating the need to develop a custom or process specific assay. This new Cygnus Technologies' CHO HCP ELISA Kit, 3G provides the specificity and sensitivity (LOD ~0.3 ng/ml, LLOQ ~1 ng/ml) to detect HCPs with reproducibility that supports regulatory compliance.