PER.C6HCP ELISA Kit, 2G

Description

The PER.C6 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 PER.C6 cells. The antibodies used in this 2nd generation PER.C6 HCP ELISA Kit, F1055, have been raised against and affinity purified using using PER.C6 cell line HCPs found in protein free conditioned media. The antibodies were characterized by Antibody Affinity Extraction AAE and Mass Spectrometry, demonstrating reactivity to majority of HCPs found in PER.C6 expression system processes. This kit has LOD 1.2 ng/ml and LLOQ 5ng/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 PER.C6 HCP ELISA Kit Item # F530. PER.C6 cell line is a registered trademark of JANSSEN VACCINES & PREVENTION B.V.