SP2/0 HCP ELISA Kit, 2G

Description

The SP2/0 HCP ELISA Kit, 2G is a simple-to-use, objective, and semi-quantitative ELISA kit intended for use in determining the presence of host cell protein impurities in products manufactured by expression in SP2/0 cells. The antibodies used in this 2nd generation SP2/0 HCP ELISA Kit, F1030, have been raised against and affinity purified using HCP recovered from culture of SP2/0 null cells in a protein-additive-free media. The antibodies were characterized by Antibody Affinity Extraction AAE and Mass Spectrometry, demonstrating 83 % coverage to HCPs in SP2/0 null culture. This kit has LOD 0.4 ng/ml and LLOQ 3ng/ml. It was qualified for testing of final product HCPs by using actual in-process and final drug substance samples. Each user of this kit is encouraged to perform a similar qualification study to demonstrate it meets their analytical needs. This kit will be replacing Cygnus SP2/0 HCP ELISA Kit, Item # F180.