The Amersham HCPQuant CHO kit is designed to quantify Chinese hamster ovary (CHO) host cell protein (HCP) contamination in process-derived samples. This HCP assay has been developed by Rockland Immunochemicals, Inc. in collaboration with GE Healthcare Life Sciences, and extensively validated. The combination of high coverage (89%) with a broad linear range (2–200 ng/mL) increases the confidence of HCP quantification in both the low and high molecular weight ranges, which is critical to managing the risk of the immunogenicity effect arising from HCP in process-derived samples. These antibodies react strongly with CHO-K1 cell lysates, showing extremely high sensitivity for cells harvested at 60–85% viability. They were generated against CHO-K1 cell lysates that were derived from cells grown in chemically-defined media.
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- Broad protein coverage and high sensitivity promote better understanding of HCP contamination and exceed the requirements of current regulatory guidelines. High coverage across the range of LMW and HMW 89% to detect more HCP.
- Robust data with low inter-plate and intra-plate variation for reliable, reproduceable results supports regulatory data submission to demonstrate risk management throughout the development process. High senstivity: LLD= 2 ng/mL and LLQ or 4ng/mL to detect low amounts of HCP.
- Broad linearity with R2=0,99 for assay range 2–200 ng/mL, requiring less optimization.
- Broad dynamic range for easy linear assay set-up saves time and uses fewer plates.
- Compatible with a wide range of buffers, with minimum matrix effect, to fit your existing workflows.
- Standard and rapid protocols are included to offer maximum flexibility.
Learn more about GE Healthcare's end-to-end solution for HCP analysis.Read more
Amersham HCPQuant CHO ELISA kit works seamlessy with GE Healthcare's 2D DIBE technology, Amersham Typhoon scanner and Melanie 9 Coverage software to provide an efficient end-to-end solution for accurately monitoring HCP. You can be confident that your results will meet regulatory requirements.
This host cell protein assay has been designed to improve the detection of CHO K1 host cell proteins in the low molecular weight (LMW) range, where other currently available products struggle. The immunogenicity effect seen in Phase III in some drugs is often due to the difficulty of measuring HCP’s in this range.
Amersham HCPQuant CHO can be used to simplify bridging studies in the late phase between Phase II and Phase III, as you transition from generic to specific ELISA assay. This can save time and money, and demonstrate to regulators management of HPC risk allthroughout process development.
The kit includes one antibody-coated 96-well plate and plate sealer, protein standard, detection antibody, and all buffers necessary to run the assay. See product specifications below for more detail.
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