Expression of therapeutic proteins in CHO cells is a cost-effective method for production of commercial quantities of therapeutic mAbs and recombinant proteins. The manufacturing and purification process of these products leaves the potential for impurities by host cell proteins (HCPs) from CHO cells.
The CHO HCP ELISA Kit, 3G (F550-1) can be used as a process development tool to monitor the removal of host cell impurities as well as for routine product release testing. The coverage of the CHO HCP antibodies to the CHO HCP antigen from CHO-S and CHO-K1 strains was determined to be ~86% by Antibody Affinity Extraction (AAE) with 2D-PAGE/Silver Stain, and 97% by AAE-MS. More importantly, Cygnus Technologies has successfully evaluated performance of the CHO HCP Antibodies (3G-0016-1-AF) in the 3G CHO ELISA (F550-1) using a panel of CHO samples from several independent biomanufacturing processes. The F550-1 “CHO 3G” HCP ELISA detected HCPs in the range of 100 parts per billion for a variety of antibodies and other therapeutic proteins expressed in CHO. This data indicated 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. Cygnus CHO HCP ELISA Kit, 3G provides specificity and sensitivity (LOD ~0.3 ng/ml, LLOQ ~1 ng/ml) to detect HCPs with reproducibility that supports regulatory compliance. Please use Sample Diluent, Item No. I028, with these kits; available separately.
Note: Cygnus CHO HCP 3rd Generation ELISA Kits, Item Number F550-1 has replaced Cygnus CHO HCP ELISA Kit, 3G, Item Number F550 in 2020.
Both Cygnus 3rd Generation CHO HCP ELISA Kits, Item Numbers F550 and F550-1, have gained global regulatory approvals for multiple commercialized biologics.
