Fast and Easy Generic Anti-CHO HCP Analysis: 96 Samples, Assay to Data in 65 Minutes with the NEW Anti-CHO HCP Detection Kit

Darick Dayne, PhD, Senior Product Manager, darick_dayne@pall.com

Pall ForteBio LLC and Cygnus Technologies recently teamed up to jointly develop our new Anti-CHO HCP Detection Kit for quantitation of residual HCPs. Cygnus HCP ELISA kits are well known for their broad HCP recognition and sensitivity, and combining their industry-standard 3G anti-CHO HCP antibody with the Octet® platform's easy and rapid high-throughput protein analysis gives you the best of both worlds for HCP assays!

LISA is the most commonly used HCP analysis method used today, but it requires multiple time-consuming incubation steps and relies on highly manual processing that introduces a lot of data variability. Octet systems can now automate the entire HCP assay process for you. Minimal hands-on time is needed and assay precision is improved by as much as 15% with better or equivalent sensitivity and dynamic range. A completely hands-off, walk-away HCP assay run on the Octet HTX system can give you fully analyzed results for 96 samples in one hour — the same assay run with ELISA can take about 3 hours. HCP assays can also be run on Octet RED384 and RED96 systems using the Sidekick Station with results in 75–90 minutes.

The Octet platform can be used for generic CHO HCP assays in early phases of clinical product development, and process-specific CHO HCP assays can also be constructed using the same assay format if a process-specific antibody has been developed. And because you can now monitor HCP data in real time, you'll be able to greatly reduce your assay development times as well.

We launched the new ForteBio-Cygnus Anti-CHO HCP Detection Kit in August and the initial feedback from customers is spectacular! Here's what one researcher from a US biotech firm on the east coast told us:

"The (Octet assay) sensitivity is quite a bit better than ELISA methods and there was no interference from our protein at 1 mg/mL. With other ELISA methods I have had to dilute to 0.2 mg/mL so the increase in sensitivity is 5-fold over that of ELISA. In addition, it would be fairly easy to adapt the technology to in- house produced antibodies against specific cell lines."

Learn more about the Anti-CHO HCP Detection Kit.

Assay Performance Cygnus 3G ELISA Kit ForteBio-Cygnus Anti-CHO HCP Detection Kit
Time-to-Result 210 min 65 min on Octet HTX system
    75 min on Octet RED384 system with Sidekick Station
    90 min on Octet RED96 system with Sidekick Station
Dynamic Range 1–100 ng/mL 0.5–200 ng/mL
Precision 15–25% 5–10%

Table 1: Comparison of overall assay performance for HCP analysis on Octet systems and ELISA for 96 samples.

Binding
Binding Rate
Expected Concentration
(ng/mL)
Calculated Concentration
(ng/mL)
% Recovery %CV
200.0 200.00 100% 4.9%
75.0 75.55 101% 1.8%
25.0 25.10 100% 1.1%
8.0 8.06 101% 2.5%
2.0 2.01 100% 0.4%
1.0 1.00 100% 0.0%
.05 0.50 100% 2.4%

Table 2: Example data from the duplicate analysis of CHO HCP standard using Anti-CHO HCP Biosensors on the Octet QKe instrument. Real time binding curves for standards (top left) and resulting dose response curve (top right) are shown. The calculated concentrations and %CV values resulting from the analysis of the data are shown in the accompanying table. 100% recoveries were obtained with %CVs that ranged from 0.0–4.9%.

Sample Set Drug Titer
(mg/mL)
In-house
HCP ELISA (ppm)
HCP Assay on Octet
Platform (ppm)
Sample A 29.4 187 331
Sample B 30.7 301 336
Sample C 28.7 374 391
Sample D 30.0 310 375
Sample E 28.7 341 396
Sample F 28.9 353 363
Sample G 1.53 154 269
Sample H 1.52 247 467
Sample I 1.61 97 181
Sample Zero 0.95 127 279

Table 3: Sample data from a major US pharmaceutical company, comparing results from an HCP ELISA assay developed in-house to an HCP assay using the Anti-CHO HCP Detection Kit on the Octet platform. Results are in very good agreement for each sample between the two methods.

  Cygnus 3G ELISA HCP Assay on Octet Platform
Samples Dilution factor Concentration
(ng/mL)
CV Dilution factor Concentration
(ng/mL)
CV
In-process Sample 1 10000
4000
20000
253714
254735
221625
5.3%
6.3%
5.6%
2000
4000
186870
200190
4.2%
5.8%
In-process Sample 2 500 4577 4.0% 100
500
2695
2577
3.5%
1.1%
In-process Sample 3 20 41 9.4% 10
20
121
106
2.6%
2.5%

Table 4: Sample data from a major European pharmaceutical company, showing excellent agreement (1–2X) in concentration values between different in-process samples using the Cygnus 3G ELISA kit and the ForteBio-Cygnus Anti-CHO HCP Detection Kit, with higher precision obtained using the Octet system.

HCP Analysis

96 SAMPLES

5%–10% CVs

65 Minutes

ELISA-LESS

Sweet!

Get all of the above with the new Anti-CHO HCP Detection Kit from Pall ForteBio LLC. We'll also throw in higher assay drug tolerance, sensitivity down to 0.5 ng/mL and a gold-standard Cygnus Technologies 3G antibody for the broadest reactivity you can get. When you run HCP assays on an Octet system, you'll have fully analyzed results in a third of the time it takes with ELISA, and not have to babysit a single step. That means shorter development times and higher quality data that's off to regulatory agencies sooner. Can't get sweeter than that!

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