Ella HCP Assay

Fast, Reproducible, Automated Host Cell Protein Measurement with Simple Plex

Summary

Host-cell proteins (HCP) are proteins produced or translated by the host organism during recombinant therapeutic proteins or biologics production. An important requirement during production is to reduce the amount of HCPs at every phase of the purification process since they complicate the efficacy of the biologic, causing immunogenicity as well an immune response when administered to a patient.

Currently, sandwich enzyme-linked immunosorbent assays (ELISAs) are the gold standard for measuring HCP abundance due to its high sensitivity and throughput. However, the 3.5-6 hours needed to perform an ELISA doesn't work for companies with a growing need to increase speed to results. ELISAs also require lots of manual wash steps and dilutions to bring samples into the quantitative range that affect accuracy and reproducibility, making good decisions hard to make. Especially when methods are run by different scientists in different labs at different sites. Finally, regulatory agencies are increasily recommending process specific assays.

Automated, Fast HCP Simple Plex Assay
  • HCP analysis in just 1 hour
  • Broader quantitative range compared to Cygnus ELISAs minimizes sample dilution requirements
  • Single-digit CVs across different users and different sites
  • Factory-generated standard curves to save you time and cost

ProteinSimple, a Bio-Techne brand, has a Simple Plex™ HCP assay that runs on Ella™, an automated immunoassay system. Simple Plex assays offer better precision, greater dynamic range at 4-5 logs, gives you results in just 1 hour. Ella also eliminates all the manual steps that lead to poor data quality and inconsistent results. Factory calibrated standard curves that come with each cartridge make it unneccessary to prepare your own standard curve in non-GMP settings, saving you significant time and cost.

Results

Figure 1.  Standard curve for the Simple Plex CHO HCP assay. Minimize the number of sample dilutions required for quantitative results with comparable LLOQ and a ULOQ that's 10X higher than Cygnus ELISAS1. CVs for quadruplicate data points were ≤ 5.7%.

CHO HCP
Standard Conc.
Simple Plex
Mean Calculated Conc.
  Day 1 Day 2
1.6 ng/mL 1.8 ng/mL 1.6 ng/mL
8 ng/mL 7.6 ng/mL 8.2 ng/mL
40 ng/mL 40.7 ng/mL 39.6 ng/mL
200 ng/mL 196.8 ng/mL 196.7 ng/mL
1000 ng/mL 1049.8 ng/mL 1053.3 ng/mL

Table 1.  Excellent quantitation reproducibility between two users using independent sample preps on different Ella instruments across two days. Ella's also consistent below LLOQ, measuring 0.28 ng/mL and 0.34 ng/mL on Day 1 and 2, respectively, for 0.32 ng/mL CHO HCP standard.

Simple Plex HCP Assay

Our HCP assays are customized to your specific HCP needs. Just send us your HCP capture and detection antibodies and HCP standards. We'll create and design your HCP Simple Plex assay for use on the Ella Instrument. The HCP assay will be formatted using the 72 x 1 cartridge which allows up to 72 individual samples to be run on a single cartridge. The procedure for processing the HCP cartridge is simple. Pipette your samples onto the cartridge, press Start in the Ella software Explorer, and the samples will be automatically processed, read, and analyzed in 1 hour. To get started, please fill out the HCP Assay Request form (link below).

Ordering Info

ITEM DESCRIPTION CATALOG NUMBER PRICE
HCP Simple Plex Assay Ten 72 x 1 cartridges for the detection of HCP for use on the Ella Instrument—User to supply antibodies SPCKB-ASSAYDEV Use HCP Assay Request form
(link below)

References

1. Cho Host Cell Proteins 3rd Generation, CYGNUS Product Insert (2015).